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TOP: Long-Term Therapy Outcomes When Treating Chronic Kidney Disease (CKD) Patients With Paricalcitol in German and Austrian Clinical Practice

Sponsor
AbbVie (prior sponsor, Abbott) (Industry)
Overall Status
Completed
CT.gov ID
NCT01083849
Collaborator
(none)
761
Enrollment
87
Locations
69
Duration (Months)
8.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to obtain data on the safety and effectiveness of Zemplar® (paricalcitol) injection and paricalcitol capsules in real-life clinical practice. Participants, who have been treated with paricalcitol in-label in an everyday setting, have been included into this study. A period of 12 months has been chosen in order to also obtain experience on the maintenance dose and treatment optimization with paricalcitol injection and paricalcitol capsules in long-term use.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    According to protocol amendment of 16 October 2010 Austria is participating in this study.

    Paricalcitol injection (intravenous (IV) therapy) was approved in Germany in December 2004 and in Austria in June 2003 for the prevention and treatment of secondary hyperparathyroidism in participants needing dialysis. In April 2008 in Germany and in January 2008 in Austria, paricalcitol capsules (for oral use (p.o.)) were launched for the prevention and treatment of secondary hyperparathyroidism in individuals with Chronic Kidney Disease stage 3 - 5 (i.e., predialysis and dialysis), thus enabling early treatment of participants with chronic kidney disease before they reach the stage of requiring dialysis.

    Postmarketing observational studies with a well-planned study design, defined study protocol and biometrical estimates are necessary for a more profound understanding of the effectiveness and adverse drug reactions, especially those that are unknown or rare.

    Accordingly, the purpose of this study is to obtain data on the safety and effectiveness of paricalcitol injection and capsules in real-life clinical practice. In this study, paricalcitol will be prescribed on an on-label basis in an everyday setting. A period of 12 months has been consciously chosen in order to also obtain experience on the maintenance dose and treatment optimization with paricalcitol injection and paricalcitol capsules in long-term use.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    761 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Long-Term Therapy Outcomes When Treating CKD-patients With Paricalcitol in German Clinical Practice (TOP Study)
    Study Start Date :
    Mar 1, 2008
    Actual Primary Completion Date :
    Dec 1, 2013
    Actual Study Completion Date :
    Dec 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    Paricalcitol

    Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants Who Achieved Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months [Up to 12 Months]

      Participants achieved Intact Parathyroid Hormone (iPTH) levels within the target range of Kidney Disease Quality Outcome Initiative (K/DOQI) treatment guidelines (Chronic Kidney Disease (CKD), stage 3: 35 to 70 pg/mL; CKD stage 4: 70 to 110 pg/mL; CKD stage 5: 150 to 300 pg/mL).

    2. Time to Achieve Target Range of Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months [Up to 12 months]

      Participants achieved Intact Parathyroid Hormone (iPTH) levels within the target range of Kidney Disease Quality Outcome Initiative (K/DOQI) treatment guidelines (Chronic Kidney Disease (CKD), stage 3: 35 to 70 pg/mL; CKD stage 4: 70 to 110 pg/mL; CKD stage 5: 150 to 300 pg/mL).

    Secondary Outcome Measures

    1. Number of Participants With Hypercalcemia [Months 0, 3, 6, 9, and 12]

      Hypercalcemia was defined as having a serum calcium level greater than 11.2 mg/dL (2.79 mmol/L), in one measurement. Serum calcium was measured at every study visit.

    2. Number of Participants With Hyperphosphatemia [Months 0, 3, 6, 9, and 12]

      Hyperphosphatemia was defined as having a serum phosphate level greater than 6.5 mg/dL (2.10 mmol/L), in one measurement. Serum phosphate was measured at every study visit.

    3. Number of Participants With Elevated Calcium-Phosphorus Product [Months 0, 3, 6, 9, and 12]

      Elevated Calcium-Phosphorus Product was defined as having a calcium-phosphate product level greater than 65 mg^2/dL^2, in one measurement. Serum calcium-phosphorus product was measured at every study visit.

    4. Mean Duration of Hospitalization by Visit [Months 0, 3, 6, 9, and 11]

    5. Mean Duration of Disability by Visit [Months 0, 3, 6, 9, and 11]

    6. Mean Intact Parathormone (iPTH) Levels by Visit [Months 0, 3, 6, 9, and 12]

    7. Mean Calcium-Phosphate Product Levels by Visit [Months 0, 3, 6, 9, and 12]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • The inclusion criteria are based on the Summary of Product Characteristics for paricalcitol injection and capsules: Prevention and therapy of secondary hyperparathyroidism in the presence of chronic kidney disease

    • Patients not treated with paricalcitol for at least 6 months prior to inclusion in this study

    Exclusion Criteria:

    • The contraindications listed in the Summary of Product Characteristics for paricalcitol injection and capsules apply

    • An additional exclusion criterion is a parathyroid hormone- value of > 1000 pg/mL (which may be a sign of tertiary hyperparathyroidism) and existing treatment with paricalcitol

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Site Reference ID/Investigator# 64522 Feldkirch Austria 6800
    2 Site Reference ID/Investigator# 53506 Graz Austria 8010
    3 Site Reference ID/Investigator# 53524 Graz Austria 8036
    4 Site Reference ID/Investigator# 74733 Innsbruck Austria 6020
    5 Site Reference ID/Investigator# 64523 Rottenmann Austria 8786
    6 Site Reference ID/Investigator# 53525 Salzburg Austria 5020
    7 Site Reference ID/Investigator# 53526 St. Poelten Austria 3100
    8 Site Reference ID/Investigator# 69662 Steyr Austria 4400
    9 Site Reference ID/Investigator# 53508 Vienna Austria 1090
    10 Site Reference ID/Investigator# 53523 Vienna Austria 1130
    11 Site Reference ID/Investigator# 53507 Vienna Austria 1220
    12 Site Reference ID/Investigator# 28352 Aachen Germany 52066
    13 Site Reference ID/Investigator# 28359 Alsfeld Germany 36304
    14 Site Reference ID/Investigator# 28305 Arnstadt Germany 99310
    15 Site Reference ID/Investigator# 28306 Aschersleben Germany 06449
    16 Site Reference ID/Investigator# 28003 Augsburg Germany 86154
    17 Site Reference ID/Investigator# 81613 Aurich Germany 26605
    18 Site Reference ID/Investigator# 28017 Bad Bevensen Germany 29549
    19 Site Reference ID/Investigator# 28301 Bad Nenndorf Germany 31542
    20 Site Reference ID/Investigator# 28296 Balingen Germany 72336
    21 Site Reference ID/Investigator# 28021 Berlin Germany 10785
    22 Site Reference ID/Investigator# 28024 Berlin Germany 12435
    23 Site Reference ID/Investigator# 28303 Berlin Germany 12627
    24 Site Reference ID/Investigator# 54050 Berlin Germany 14193
    25 Site Reference ID/Investigator# 28022 Bernburg Germany 06406
    26 Site Reference ID/Investigator# 30862 Betzdorf Germany 57518
    27 Site Reference ID/Investigator# 28007 Bielefeld Germany 33609
    28 Site Reference ID/Investigator# 28304 Burg Germany 39288
    29 Site Reference ID/Investigator# 28014 Coburg Germany 96450
    30 Site Reference ID/Investigator# 28023 Cottbus Germany 03046
    31 Site Reference ID/Investigator# 28134 Demmin Germany 17109
    32 Site Reference ID/Investigator# 28037 Dresden Germany 01217
    33 Site Reference ID/Investigator# 43903 Dresden Germany 01307
    34 Site Reference ID/Investigator# 99777 Elmshorn Germany 25337
    35 Site Reference ID/Investigator# 28284 Elsenfeld Germany 63820
    36 Site Reference ID/Investigator# 124118 Emden Germany 26721
    37 Site Reference ID/Investigator# 54054 Emsdetten Germany 48282
    38 Site Reference ID/Investigator# 48864 Erfurt Germany 99089
    39 Site Reference ID/Investigator# 72343 Erkelenz Germany 41812
    40 Site Reference ID/Investigator# 28029 Eschweiler Germany 52249
    41 Site Reference ID/Investigator# 28287 Friedrichroda Germany 99894
    42 Site Reference ID/Investigator# 28276 Gera Germany 07548
    43 Site Reference ID/Investigator# 28351 Halle Germany 06118
    44 Site Reference ID/Investigator# 28280 Hamburg Germany 22767
    45 Site Reference ID/Investigator# 48865 Hanover Germany 30625
    46 Site Reference ID/Investigator# 28300 Heilbronn Germany 74076
    47 Site Reference ID/Investigator# 28011 Herford Germany 32049
    48 Site Reference ID/Investigator# 124119 Herne Germany 44623
    49 Site Reference ID/Investigator# 28019 Herzberg Germany 04916
    50 Site Reference ID/Investigator# 28135 Hildesheim Germany 31134
    51 Site Reference ID/Investigator# 28286 Hoyerswerda Germany 02977
    52 Site Reference ID/Investigator# 28353 Ilfeld Germany 99768
    53 Site Reference ID/Investigator# 28044 Jena Germany 07743
    54 Site Reference ID/Investigator# 48863 Kiel Germany 24106
    55 Site Reference ID/Investigator# 28013 Lahr Germany 77933
    56 Site Reference ID/Investigator# 28025 Loerrach Germany 79539
    57 Site Reference ID/Investigator# 28290 Ludwigslust Germany 19288
    58 Site Reference ID/Investigator# 10982 Magdeburg Germany 39108
    59 Site Reference ID/Investigator# 28291 Malente Germany 23714
    60 Site Reference ID/Investigator# 28036 Mannheim Germany 68309
    61 Site Reference ID/Investigator# 28302 Marburg Germany 35043
    62 Site Reference ID/Investigator# 54051 Minden Germany 32429
    63 Site Reference ID/Investigator# 28278 Muellheim Germany 79379
    64 Site Reference ID/Investigator# 99778 Munich Germany 80336
    65 Site Reference ID/Investigator# 99776 Neumuenster Germany 24534
    66 Site Reference ID/Investigator# 124120 Nordhorn Germany 48527
    67 Site Reference ID/Investigator# 28275 Nordhorn Germany 48529
    68 Site Reference ID/Investigator# 43904 Oberstdorf Germany 87561
    69 Site Reference ID/Investigator# 28277 Osnabrueck Germany 49074
    70 Site Reference ID/Investigator# 28297 Peine Germany 31224
    71 Site Reference ID/Investigator# 28307 Pirmasens Germany 66953
    72 Site Reference ID/Investigator# 28295 Potsdam Germany 14482
    73 Site Reference ID/Investigator# 28294 Quedlinburg Germany 06484
    74 Site Reference ID/Investigator# 48862 Rendsburg Germany 24768
    75 Site Reference ID/Investigator# 28042 Ribnitz-Damgarten Germany 18311
    76 Site Reference ID/Investigator# 28282 Rostock Germany 18107
    77 Site Reference ID/Investigator# 28033 St. Wendel Germany 66606
    78 Site Reference ID/Investigator# 54052 Stuttgart Germany 70199
    79 Site Reference ID/Investigator# 28005 Stuttgart Germany 70376
    80 Site Reference ID/Investigator# 28020 Viersen Germany 41751
    81 Site Reference ID/Investigator# 28293 Villingen-Schwenningen Germany 78054
    82 Site Reference ID/Investigator# 28018 Voelklingen Germany 66333
    83 Site Reference ID/Investigator# 28298 Weissenfels Germany 06667
    84 Site Reference ID/Investigator# 28292 Wetzlar Germany 35578
    85 Site Reference ID/Investigator# 48882 Wiesbaden Germany 65191
    86 Site Reference ID/Investigator# 28299 Wolfenbuettel Germany 38304
    87 Site Reference ID/Investigator# 28279 Zwickau Germany 08056

    Sponsors and Collaborators

    • AbbVie (prior sponsor, Abbott)

    Investigators

    • Study Director: Sabine Decker-Burgard, MD, AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    AbbVie (prior sponsor, Abbott)
    ClinicalTrials.gov Identifier:
    NCT01083849
    Other Study ID Numbers:
    • P10-681
    First Posted:
    Mar 10, 2010
    Last Update Posted:
    Dec 19, 2014
    Last Verified:
    Dec 1, 2014
    Keywords provided by AbbVie (prior sponsor, Abbott)
    Observational study
    Paricalcitol
    Treatment of Hyperparathyroidism
    Chronic kidney disease stage 3, 4 and 5 (CKD stage 3, 4 and 5)
    Chronic Kidney Disease
    Zemplar
    sHPT
    Secondary
    Additional relevant MeSH terms:
    Kidney Diseases
    Renal Insufficiency, Chronic
    Renal Insufficiency
    Hyperparathyroidism
    Hyperparathyroidism, Secondary

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail 761 participants were enrolled in the study, but two participants lacked information necessary for assignment to one of the analysis groups (pre-dialysis or dialysis). Hence, analysis was conducted with 759 participants.
    Arm/Group Title Paricalcitol Pre-dialysis Group Paricalcitol Dialysis Group
    Arm/Group Description Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months. Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
    Period Title: Overall Study
    STARTED 121 638
    COMPLETED 61 527
    NOT COMPLETED 60 111

    Baseline Characteristics

    Arm/Group Title Paricalcitol Pre-dialysis Group Paricalcitol Dialysis Group Total
    Arm/Group Description Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months. Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months. Total of all reporting groups
    Overall Participants 121 638 759
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    64.2
    (13.9)
    62.5
    (14.9)
    62.8
    (14.8)
    Sex: Female, Male (Count of Participants)
    Female
    47
    38.8%
    291
    45.6%
    338
    44.5%
    Male
    74
    61.2%
    347
    54.4%
    421
    55.5%
    Duration of Chronic Kidney Disease (months) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [months]
    39.3
    (36.0)
    71.2
    (61.1)
    67.5
    (59.6)
    Duration of Secondary Hyperparathyroidism (months) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [months]
    17.7
    (20.6)
    43.9
    (36.6)
    39.5
    (35.8)

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Participants Who Achieved Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months
    Description Participants achieved Intact Parathyroid Hormone (iPTH) levels within the target range of Kidney Disease Quality Outcome Initiative (K/DOQI) treatment guidelines (Chronic Kidney Disease (CKD), stage 3: 35 to 70 pg/mL; CKD stage 4: 70 to 110 pg/mL; CKD stage 5: 150 to 300 pg/mL).
    Time Frame Up to 12 Months

    Outcome Measure Data

    Analysis Population Description
    Participants with a determined chronic kidney disease (CKD) stage
    Arm/Group Title Paricalcitol
    Arm/Group Description Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, not treated with paricalcitol for at least 6 months prior inclusion in this study, received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
    Measure Participants 718
    Stage 3 [N=56]
    30.4
    25.1%
    Stage 4 [N=82]
    30.5
    25.2%
    Stage 5 [N=580]
    70.2
    58%
    2. Secondary Outcome
    Title Number of Participants With Hypercalcemia
    Description Hypercalcemia was defined as having a serum calcium level greater than 11.2 mg/dL (2.79 mmol/L), in one measurement. Serum calcium was measured at every study visit.
    Time Frame Months 0, 3, 6, 9, and 12

    Outcome Measure Data

    Analysis Population Description
    The Pre-Dialysis and Dialysis groups were split into subgroups. Secondary endpoint investigations were done for the 733 participants in these Pre-Dialysis or Dialysis subgroups; 26 out of the 759 participants had a missing subgroup allocation.
    Arm/Group Title Paricalcitol Pre-dialysis Group Paricalcitol Dialysis Group
    Arm/Group Description Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, prescribed on an on-label basis in an everyday setting. Participants were observed for 12 months. Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, prescribed on an on-label basis in an everyday setting. Participants were observed for 12 months.
    Measure Participants 96 637
    Month 0
    1
    0.8%
    2
    0.3%
    Month 3
    2
    1.7%
    6
    0.9%
    Month 6
    1
    0.8%
    4
    0.6%
    Month 9
    1
    0.8%
    4
    0.6%
    Month 12
    1
    0.8%
    5
    0.8%
    3. Secondary Outcome
    Title Number of Participants With Hyperphosphatemia
    Description Hyperphosphatemia was defined as having a serum phosphate level greater than 6.5 mg/dL (2.10 mmol/L), in one measurement. Serum phosphate was measured at every study visit.
    Time Frame Months 0, 3, 6, 9, and 12

    Outcome Measure Data

    Analysis Population Description
    The Pre-Dialysis and Dialysis groups were split into subgroups. Secondary endpoint investigations were done for the 733 participants in these Pre-Dialysis or Dialysis subgroups; 26 out of the 759 participants had a missing subgroup allocation.
    Arm/Group Title Paricalcitol Pre-dialysis Group Paricalcitol Dialysis Group
    Arm/Group Description Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months. Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
    Measure Participants 96 637
    Month 0
    5
    4.1%
    192
    30.1%
    Month 3
    8
    6.6%
    153
    24%
    Month 6
    8
    6.6%
    151
    23.7%
    Month 9
    9
    7.4%
    133
    20.8%
    Month 12
    8
    6.6%
    128
    20.1%
    4. Secondary Outcome
    Title Number of Participants With Elevated Calcium-Phosphorus Product
    Description Elevated Calcium-Phosphorus Product was defined as having a calcium-phosphate product level greater than 65 mg^2/dL^2, in one measurement. Serum calcium-phosphorus product was measured at every study visit.
    Time Frame Months 0, 3, 6, 9, and 12

    Outcome Measure Data

    Analysis Population Description
    The Pre-Dialysis and Dialysis groups were split into subgroups. Secondary endpoint investigations were done for the 733 participants in these Pre-Dialysis or Dialysis subgroups; 26 out of the 759 participants had a missing subgroup allocation.
    Arm/Group Title Paricalcitol Pre-dialysis Group Paricalcitol Dialysis Group
    Arm/Group Description Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months. Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
    Measure Participants 96 637
    Month 0
    5
    4.1%
    102
    16%
    Month 3
    6
    5%
    97
    15.2%
    Month 6
    7
    5.8%
    101
    15.8%
    Month 9
    6
    5%
    89
    13.9%
    Month 12
    4
    3.3%
    78
    12.2%
    5. Secondary Outcome
    Title Mean Duration of Hospitalization by Visit
    Description
    Time Frame Months 0, 3, 6, 9, and 11

    Outcome Measure Data

    Analysis Population Description
    The Pre-Dialysis and Dialysis groups were split into subgroups. Secondary endpoint investigations were done for the 733 participants in these Pre-Dialysis or Dialysis subgroups; 26 out of the 759 participants had a missing subgroup allocation.
    Arm/Group Title Paricalcitol Pre-dialysis Group Paricalcitol Dialysis Group
    Arm/Group Description Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months. Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
    Measure Participants 96 637
    Month 0
    1.3
    (4.9)
    0.7
    (4.0)
    Month 3
    1.8
    (4.4)
    0.8
    (3.5)
    Month 6
    2.9
    (5.9)
    0.8
    (4.3)
    Month 9
    0.0
    (0.0)
    0.8
    (3.5)
    Month 11
    0.9
    (4.0)
    0.6
    (3.9)
    6. Secondary Outcome
    Title Mean Duration of Disability by Visit
    Description
    Time Frame Months 0, 3, 6, 9, and 11

    Outcome Measure Data

    Analysis Population Description
    The Pre-Dialysis and Dialysis groups were split into subgroups. Secondary endpoint investigations were done for the 733 participants in these Pre-Dialysis or Dialysis subgroups; 26 out of the 759 participants had a missing subgroup allocation.
    Arm/Group Title Paricalcitol Pre-dialysis Group Paricalcitol Dialysis Group
    Arm/Group Description Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months. Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
    Measure Participants 96 637
    Month 0
    0.0
    (0.0)
    0.3
    (3.0)
    Month 3
    4.7
    (8.1)
    0.2
    (2.0)
    Month 6
    0.0
    (0.0)
    0.4
    (3.5)
    Month 9
    0.0
    (0.0)
    0.4
    (3.1)
    Month 11
    0.3
    (1.0)
    0.4
    (3.2)
    7. Primary Outcome
    Title Time to Achieve Target Range of Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months
    Description Participants achieved Intact Parathyroid Hormone (iPTH) levels within the target range of Kidney Disease Quality Outcome Initiative (K/DOQI) treatment guidelines (Chronic Kidney Disease (CKD), stage 3: 35 to 70 pg/mL; CKD stage 4: 70 to 110 pg/mL; CKD stage 5: 150 to 300 pg/mL).
    Time Frame Up to 12 months

    Outcome Measure Data

    Analysis Population Description
    Participants with a determined chronic kidney disease (CKD) stage
    Arm/Group Title Paricalcitol
    Arm/Group Description Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, not treated with paricalcitol for at least 6 months prior inclusion in this study, received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
    Measure Participants 718
    Stage 3 [N=17]
    212.4
    (203.93)
    Stage 4 [N=25]
    195.5
    (118.3)
    Stage 5 [N=407]
    145.7
    (107.1)
    8. Secondary Outcome
    Title Mean Intact Parathormone (iPTH) Levels by Visit
    Description
    Time Frame Months 0, 3, 6, 9, and 12

    Outcome Measure Data

    Analysis Population Description
    The Pre-Dialysis and Dialysis groups were split into subgroups. Secondary endpoint investigations were done for the 733 participants in these Pre-Dialysis or Dialysis subgroups; 26 out of the 759 participants had a missing subgroup allocation.
    Arm/Group Title Paricalcitol Pre-dialysis Group Paricalcitol Dialysis Group
    Arm/Group Description Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months. Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
    Measure Participants 96 637
    Month 0
    29.65
    (26.95)
    54.85
    (29.51)
    Month 3
    26.95
    (36.94)
    37.20
    (28.35)
    Month 6
    23.01
    (27.32)
    37.18
    (30.08)
    Month 9
    27.85
    (33.95)
    36.54
    (29.42)
    Month 12
    29.57
    (31.28)
    38.24
    (33.76)
    9. Secondary Outcome
    Title Mean Calcium-Phosphate Product Levels by Visit
    Description
    Time Frame Months 0, 3, 6, 9, and 12

    Outcome Measure Data

    Analysis Population Description
    The Pre-Dialysis and Dialysis groups were split into subgroups. Secondary endpoint investigations were done for the 733 participants in these Pre-Dialysis or Dialysis subgroups; 26 out of the 759 participants had a missing subgroup allocation.
    Arm/Group Title Paricalcitol Pre-dialysis Group Paricalcitol Dialysis Group
    Arm/Group Description Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months. Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
    Measure Participants 96 637
    Month 0
    3.32
    (3.12)
    4.12
    (1.29)
    Month 3
    3.50
    (1.46)
    4.30
    (1.26)
    Month 6
    3.62
    (1.61)
    4.32
    (1.22)
    Month 9
    3.61
    (1.37)
    4.25
    (1.29)
    Month 12
    3.48
    (1.20)
    4.21
    (1.31)

    Adverse Events

    Time Frame Adverse events (AEs) occurring during the 12-month observation period from the date of initiation of paricalcitol treatment plus 30 days after the end of that period had to be recorded.
    Adverse Event Reporting Description Adverse Event investigations were done for the 733 participants which were in the predialysis (N=96) or dialysis subgroups (N=637).
    Arm/Group Title Paricalcitol Pre-dialysis Group Paricalcitol Dialysis Group
    Arm/Group Description Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months. Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
    All Cause Mortality
    Paricalcitol Pre-dialysis Group Paricalcitol Dialysis Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Paricalcitol Pre-dialysis Group Paricalcitol Dialysis Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 16/96 (16.7%) 186/637 (29.2%)
    Blood and lymphatic system disorders
    Anaemia 0/96 (0%) 2/637 (0.3%)
    Haemorrhagic anaemia 2/96 (2.1%) 0/637 (0%)
    Cardiac disorders
    Acute myocardial infarction 0/96 (0%) 1/637 (0.2%)
    Angina pectoris 0/96 (0%) 1/637 (0.2%)
    Aortic valve disease mixed 0/96 (0%) 1/637 (0.2%)
    Aortic valve stenosis 1/96 (1%) 2/637 (0.3%)
    Arrhythmia 0/96 (0%) 2/637 (0.3%)
    Atrial fibrillation 0/96 (0%) 1/637 (0.2%)
    Cardiac arrest 1/96 (1%) 3/637 (0.5%)
    Cardiac failure 0/96 (0%) 5/637 (0.8%)
    Cardiac tamponade 1/96 (1%) 0/637 (0%)
    Cardiopulmonary failure 1/96 (1%) 0/637 (0%)
    Cardiovascular disorder 0/96 (0%) 1/637 (0.2%)
    Coronary artery disease 2/96 (2.1%) 3/637 (0.5%)
    Left ventricular dysfunction 0/96 (0%) 1/637 (0.2%)
    Left ventricular failure 0/96 (0%) 1/637 (0.2%)
    Mitral valve incompetence 0/96 (0%) 1/637 (0.2%)
    Myocardial infarction 0/96 (0%) 4/637 (0.6%)
    Ventricular fibrillation 1/96 (1%) 1/637 (0.2%)
    Congenital, familial and genetic disorders
    Congenital cystic kidney disease 0/96 (0%) 1/637 (0.2%)
    Eye disorders
    Amaurosis 0/96 (0%) 1/637 (0.2%)
    Cataract 0/96 (0%) 1/637 (0.2%)
    Optic ischaemic neuropathy 0/96 (0%) 1/637 (0.2%)
    Vitreous haemorrhage 0/96 (0%) 1/637 (0.2%)
    Gastrointestinal disorders
    Anal haemorrhage 0/96 (0%) 2/637 (0.3%)
    Diarrhoea 0/96 (0%) 2/637 (0.3%)
    Diverticular hernia 0/96 (0%) 1/637 (0.2%)
    Enterocolitis 0/96 (0%) 1/637 (0.2%)
    Gastric ulcer 0/96 (0%) 1/637 (0.2%)
    Gastritis 0/96 (0%) 1/637 (0.2%)
    Gastritis haemorrhagic 1/96 (1%) 0/637 (0%)
    Gastrointestinal haemorrhage 3/96 (3.1%) 2/637 (0.3%)
    Haematochezia 0/96 (0%) 1/637 (0.2%)
    Ileus 0/96 (0%) 2/637 (0.3%)
    Intestinal ischaemia 0/96 (0%) 1/637 (0.2%)
    Mesenteric vein thrombosis 0/96 (0%) 1/637 (0.2%)
    Oesophagitis 0/96 (0%) 1/637 (0.2%)
    Subileus 0/96 (0%) 1/637 (0.2%)
    General disorders
    Asthenia 0/96 (0%) 1/637 (0.2%)
    Cardiac death 0/96 (0%) 1/637 (0.2%)
    Chest pain 0/96 (0%) 2/637 (0.3%)
    Death 1/96 (1%) 13/637 (2%)
    Device dislocation 0/96 (0%) 3/637 (0.5%)
    Device malfunction 0/96 (0%) 2/637 (0.3%)
    Device occlusion 0/96 (0%) 1/637 (0.2%)
    Fat necrosis 0/96 (0%) 1/637 (0.2%)
    General physical health deterioration 0/96 (0%) 2/637 (0.3%)
    Hernia obstructive 0/96 (0%) 1/637 (0.2%)
    Hyperplasia 0/96 (0%) 1/637 (0.2%)
    Impaired healing 0/96 (0%) 1/637 (0.2%)
    Inflammation 0/96 (0%) 1/637 (0.2%)
    Local swelling 0/96 (0%) 1/637 (0.2%)
    Multi-organ failure 0/96 (0%) 1/637 (0.2%)
    Pain 0/96 (0%) 2/637 (0.3%)
    Sudden cardiac death 0/96 (0%) 3/637 (0.5%)
    Sudden death 0/96 (0%) 1/637 (0.2%)
    Ulcer 0/96 (0%) 1/637 (0.2%)
    Hepatobiliary disorders
    Cholangitis 0/96 (0%) 1/637 (0.2%)
    Hepatic cirrhosis 0/96 (0%) 1/637 (0.2%)
    Immune system disorders
    Liver transplant rejection 0/96 (0%) 1/637 (0.2%)
    Infections and infestations
    Abdominal wall abscess 0/96 (0%) 1/637 (0.2%)
    Appendicitis 1/96 (1%) 1/637 (0.2%)
    Catheter site infection 0/96 (0%) 1/637 (0.2%)
    Cellulitis 0/96 (0%) 2/637 (0.3%)
    Cerebral toxoplasmosis 1/96 (1%) 0/637 (0%)
    Device related infection 0/96 (0%) 2/637 (0.3%)
    Device related sepsis 0/96 (0%) 1/637 (0.2%)
    Empyema 0/96 (0%) 1/637 (0.2%)
    Endocarditis 0/96 (0%) 1/637 (0.2%)
    Erysipelas 0/96 (0%) 2/637 (0.3%)
    Escherichia urinary tract infection 0/96 (0%) 1/637 (0.2%)
    Gangrene 0/96 (0%) 1/637 (0.2%)
    Gastroenteritis 1/96 (1%) 1/637 (0.2%)
    Infection 0/96 (0%) 2/637 (0.3%)
    Intervertebral discitis 0/96 (0%) 1/637 (0.2%)
    Lyme disease 0/96 (0%) 1/637 (0.2%)
    Osteomyelitis 0/96 (0%) 1/637 (0.2%)
    Peritonitis 0/96 (0%) 3/637 (0.5%)
    Pneumonia 0/96 (0%) 4/637 (0.6%)
    Sepsis 0/96 (0%) 8/637 (1.3%)
    Sinusitis 0/96 (0%) 1/637 (0.2%)
    Soft tissue infection 0/96 (0%) 1/637 (0.2%)
    Superinfection bacterial 0/96 (0%) 1/637 (0.2%)
    Upper respiratory tract infection 0/96 (0%) 1/637 (0.2%)
    Injury, poisoning and procedural complications
    Ankle fracture 0/96 (0%) 1/637 (0.2%)
    Arteriovenous fistula occlusion 0/96 (0%) 1/637 (0.2%)
    Arteriovenous fistula site haemorrhage 0/96 (0%) 1/637 (0.2%)
    Cervical vertebral fracture 0/96 (0%) 2/637 (0.3%)
    Excoriation 0/96 (0%) 1/637 (0.2%)
    Fall 0/96 (0%) 4/637 (0.6%)
    Femoral neck fracture 0/96 (0%) 3/637 (0.5%)
    Haemodialysis complication 0/96 (0%) 1/637 (0.2%)
    Pelvic fracture 0/96 (0%) 1/637 (0.2%)
    Post procedural stroke 0/96 (0%) 1/637 (0.2%)
    Radius fracture 0/96 (0%) 1/637 (0.2%)
    Rib fracture 0/96 (0%) 1/637 (0.2%)
    Shunt aneurysm 0/96 (0%) 1/637 (0.2%)
    Shunt malfunction 0/96 (0%) 2/637 (0.3%)
    Shunt occlusion 0/96 (0%) 12/637 (1.9%)
    Shunt stenosis 0/96 (0%) 1/637 (0.2%)
    Shunt thrombosis 0/96 (0%) 2/637 (0.3%)
    Skin injury 0/96 (0%) 1/637 (0.2%)
    Vascular graft occlusion 0/96 (0%) 2/637 (0.3%)
    Investigations
    Angiogram 0/96 (0%) 1/637 (0.2%)
    Arteriogram coronary 0/96 (0%) 1/637 (0.2%)
    Blood parathyroid hormone increased 0/96 (0%) 1/637 (0.2%)
    Catheterisation cardiac 0/96 (0%) 2/637 (0.3%)
    Colonoscopy 0/96 (0%) 1/637 (0.2%)
    C-reactive protein increased 0/96 (0%) 1/637 (0.2%)
    Endoscopy 0/96 (0%) 1/637 (0.2%)
    Endoscopy upper gastrointestinal tract 0/96 (0%) 2/637 (0.3%)
    Investigation 0/96 (0%) 1/637 (0.2%)
    Weight decreased 0/96 (0%) 1/637 (0.2%)
    Metabolism and nutrition disorders
    Calciphylaxis 0/96 (0%) 2/637 (0.3%)
    Diabetes mellitus inadequate control 0/96 (0%) 1/637 (0.2%)
    Fluid overload 0/96 (0%) 2/637 (0.3%)
    Hyperuricaemia 1/96 (1%) 0/637 (0%)
    Hypoalbuminaemia 1/96 (1%) 0/637 (0%)
    Hypoglycaemia 0/96 (0%) 1/637 (0.2%)
    Hypoproteinaemia 1/96 (1%) 0/637 (0%)
    Musculoskeletal and connective tissue disorders
    Arthritis 0/96 (0%) 1/637 (0.2%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenoma benign 0/96 (0%) 1/637 (0.2%)
    Brain neoplasm 0/96 (0%) 1/637 (0.2%)
    Bronchial carcinoma 0/96 (0%) 2/637 (0.3%)
    Lymphoma 0/96 (0%) 1/637 (0.2%)
    Metastases to central nervous system 0/96 (0%) 1/637 (0.2%)
    Metastases to liver 0/96 (0%) 1/637 (0.2%)
    Myelofibrosis 0/96 (0%) 1/637 (0.2%)
    Prostate cancer 1/96 (1%) 0/637 (0%)
    Renal cell carcinoma 0/96 (0%) 1/637 (0.2%)
    Transitional cell carcinoma 0/96 (0%) 1/637 (0.2%)
    Nervous system disorders
    Altered state of consciousness 0/96 (0%) 1/637 (0.2%)
    Cerebral haemorrhage 0/96 (0%) 1/637 (0.2%)
    Cerebral infarction 0/96 (0%) 1/637 (0.2%)
    Cerebrovascular accident 0/96 (0%) 1/637 (0.2%)
    Dementia 0/96 (0%) 1/637 (0.2%)
    Dementia Alzheimer's type 0/96 (0%) 1/637 (0.2%)
    Diabetic neuropathy 0/96 (0%) 1/637 (0.2%)
    Epilepsy 0/96 (0%) 1/637 (0.2%)
    IIIrd nerve paresis 0/96 (0%) 1/637 (0.2%)
    Presyncope 0/96 (0%) 1/637 (0.2%)
    Restless legs syndrome 0/96 (0%) 1/637 (0.2%)
    Syncope 1/96 (1%) 3/637 (0.5%)
    Transient ischaemic attack 0/96 (0%) 1/637 (0.2%)
    Vascular encephalopathy 0/96 (0%) 1/637 (0.2%)
    Psychiatric disorders
    Restlessness 0/96 (0%) 1/637 (0.2%)
    Renal and urinary disorders
    Haematuria 0/96 (0%) 1/637 (0.2%)
    Nephrolithiasis 0/96 (0%) 1/637 (0.2%)
    Proteinuria 1/96 (1%) 0/637 (0%)
    Renal failure 1/96 (1%) 0/637 (0%)
    Renal failure acute 1/96 (1%) 0/637 (0%)
    Renal impairment 1/96 (1%) 0/637 (0%)
    Reproductive system and breast disorders
    Adenomyosis 0/96 (0%) 1/637 (0.2%)
    Menorrhagia 0/96 (0%) 1/637 (0.2%)
    Respiratory, thoracic and mediastinal disorders
    Aspiration 0/96 (0%) 1/637 (0.2%)
    Dyspnoea 0/96 (0%) 3/637 (0.5%)
    Dyspnoea exertional 0/96 (0%) 2/637 (0.3%)
    Emphysema 0/96 (0%) 1/637 (0.2%)
    Pulmonary embolism 1/96 (1%) 0/637 (0%)
    Pulmonary hypertension 1/96 (1%) 0/637 (0%)
    Pulmonary oedema 1/96 (1%) 1/637 (0.2%)
    Skin and subcutaneous tissue disorders
    Diabetic foot 0/96 (0%) 5/637 (0.8%)
    Drug eruption 1/96 (1%) 0/637 (0%)
    Eczema 0/96 (0%) 1/637 (0.2%)
    Skin ulcer 0/96 (0%) 2/637 (0.3%)
    Surgical and medical procedures
    Abscess management 0/96 (0%) 1/637 (0.2%)
    Angioplasty 0/96 (0%) 1/637 (0.2%)
    Aortic valve replacement 0/96 (0%) 1/637 (0.2%)
    Arteriovenous fistula operation 1/96 (1%) 8/637 (1.3%)
    Arteriovenous shunt operation 1/96 (1%) 3/637 (0.5%)
    Cardiac pacemaker insertion 1/96 (1%) 1/637 (0.2%)
    Cataract operation 0/96 (0%) 1/637 (0.2%)
    Catheter placement 1/96 (1%) 1/637 (0.2%)
    Central venous catheterisation 0/96 (0%) 3/637 (0.5%)
    Cholecystectomy 0/96 (0%) 1/637 (0.2%)
    Dialysis 1/96 (1%) 0/637 (0%)
    Foot amputation 0/96 (0%) 1/637 (0.2%)
    Hospitalisation 0/96 (0%) 7/637 (1.1%)
    Inguinal hernia repair 0/96 (0%) 1/637 (0.2%)
    Leg amputation 0/96 (0%) 3/637 (0.5%)
    Mitral valve repair 0/96 (0%) 1/637 (0.2%)
    Nephrectomy 0/96 (0%) 1/637 (0.2%)
    Parathyroid gland operation 0/96 (0%) 1/637 (0.2%)
    Parathyroidectomy 0/96 (0%) 2/637 (0.3%)
    Rehabilitation therapy 0/96 (0%) 1/637 (0.2%)
    Removal of ambulatory peritoneal catheter 0/96 (0%) 1/637 (0.2%)
    Renal transplant 0/96 (0%) 3/637 (0.5%)
    Resection of rectum 0/96 (0%) 1/637 (0.2%)
    Stent placement 0/96 (0%) 1/637 (0.2%)
    Thyroidectomy 0/96 (0%) 3/637 (0.5%)
    Toe amputation 0/96 (0%) 2/637 (0.3%)
    Transplant 0/96 (0%) 1/637 (0.2%)
    Umbilical hernia repair 0/96 (0%) 1/637 (0.2%)
    Urinary tract operation 0/96 (0%) 1/637 (0.2%)
    Venous operation 0/96 (0%) 1/637 (0.2%)
    Vascular disorders
    Arterial occlusive disease 0/96 (0%) 2/637 (0.3%)
    Arteriosclerosis 0/96 (0%) 1/637 (0.2%)
    Circulatory collapse 0/96 (0%) 2/637 (0.3%)
    Extremity necrosis 0/96 (0%) 3/637 (0.5%)
    Haemorrhage 0/96 (0%) 1/637 (0.2%)
    Hypertensive crisis 0/96 (0%) 8/637 (1.3%)
    Peripheral arterial occlusive disease 0/96 (0%) 9/637 (1.4%)
    Poor peripheral circulation 0/96 (0%) 1/637 (0.2%)
    Steal syndrome 0/96 (0%) 1/637 (0.2%)
    Subclavian artery occlusion 0/96 (0%) 1/637 (0.2%)
    Vasculitis 0/96 (0%) 1/637 (0.2%)
    Other (Not Including Serious) Adverse Events
    Paricalcitol Pre-dialysis Group Paricalcitol Dialysis Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/96 (0%) 0/637 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.

    Results Point of Contact

    Name/Title Global Medical Services
    Organization AbbVie (prior sponsor, Abbott)
    Phone 800-633-9110
    Email
    Responsible Party:
    AbbVie (prior sponsor, Abbott)
    ClinicalTrials.gov Identifier:
    NCT01083849
    Other Study ID Numbers:
    • P10-681
    First Posted:
    Mar 10, 2010
    Last Update Posted:
    Dec 19, 2014
    Last Verified:
    Dec 1, 2014