Transition to Ferric Citrate Among Hemodialysis and Peritoneal Dialysis Patients

Sponsor
Kaiser Permanente (Other)
Overall Status
Completed
CT.gov ID
NCT03079869
Collaborator
Keryx Biopharmaceuticals (Industry)
55
1
1
28.5
1.9

Study Details

Study Description

Brief Summary

Transition to Ferric Citrate among Hemodialysis and Peritoneal Dialysis Patients: A Phase 4 "Real World" Experience Study from Kaiser Permanente Southern California

Condition or Disease Intervention/Treatment Phase
  • Drug: Ferric Citrate
Phase 4

Detailed Description

PROTOCOL SUMMARY

Title: Transition to Ferric Citrate among Hemodialysis and Peritoneal Dialysis Patients: A Phase 4 "Real World" Experience Study from Kaiser Permanente Southern California

Short Title: FeCitrate

Protocol Number: KP FeCitrate

Study Phase: 4

Study Site(s): Los Angeles Kaiser Sunset Medical Center

Number of Subjects: 55

Study Arms: 1

Indication: Hyperphosphatemia in end stage renal disease

Primary Purpose: To evaluate the efficacy of ferric citrate for control of serum phosphorus levels and maintenance of adequate iron stores among dialysis-dependent patients before and after conversion from traditional phosphate binders in a "real world" environment

Overview of Study Design: Prospective non-randomized cohort study of 6-9 months duration (active study period 6 months).

Investigational Product Administration: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption.

Study Endpoint: Mean serum phosphorus levels and rate of successful phosphorus control (<5.5mg/dl) 6 months before and after treatment with ferric citrate

Statistical Methods: Not powered to detect statistical significance

Study Design

Study Type:
Interventional
Actual Enrollment :
55 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Prospective non-randomized cohort study of 6-9 months duration (active study period 6 months).Prospective non-randomized cohort study of 6-9 months duration (active study period 6 months).
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Transition to Ferric Citrate Among Hemodialysis and Peritoneal Dialysis Patients: A Phase 4 "Real World" Experience Study From Kaiser Permanente Southern California
Actual Study Start Date :
May 1, 2017
Actual Primary Completion Date :
Sep 14, 2019
Actual Study Completion Date :
Sep 14, 2019

Arms and Interventions

Arm Intervention/Treatment
Other: Ferric Citrate

Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles.

Drug: Ferric Citrate
One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption.
Other Names:
  • Auryxia
  • Outcome Measures

    Primary Outcome Measures

    1. Phosphorus Levels [6 months]

      Serum phosphorus levels measured by mg/dL from the 6 months prior to enrollment were compared to serum phosphorus levels collected during the 6 months of ferric citrate use

    Secondary Outcome Measures

    1. Intravenous (IV) Iron [6 months]

      The amount of intravenous (IV) iron in mg used per month by participants for 6 months before and 6 months on Ferric Citrate treatment.

    2. Erythropoiesis Stimulating Agents (ESA) Dose [6 months]

      Mean Erythropoiesis Stimulating Agents (ESA) use from the 6 months prior to enrollment were compared to ESA use during the 6 months of ferric citrate use. The mean ESA dose units given to each participant per month was used in the analysis of this outcome.

    3. Median Pill Count [6 months]

      median pill count of ferric citrate pills/day required to maintain phosphorus control

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Currently using 3 to 18 pills per day of calcium acetate, sevelamer, lanthanum, or calcium carbonate

    • Mean serum phosphorus 4.0-<8.0 mg/dl for 6 months prior to enrollment

    • No allergy to iron

    • Mean corrected serum calcium > 8.0 mg/dl for 6 months prior to enrollment

    • Mean PTH < 1000 pg/ml for 6 months prior to enrollment

    • Mean ferritin < 1500 ng/ml and mean iron sat < 50% for 6 months prior to enrollment

    Exclusion Criteria:
    • History of gastrointestinal bleeding within past 6 months

    • History of hospitalization for gastroparesis, bowel obstruction, or abdominal surgery within past 6 months

    • Acute kidney injury equal to or less than 3 months before the initial screening date

    • Active malignancy

    • Functioning renal transplant

    • Patients with iron overload syndrome (e.g., Hemochromatosis)

    • History autoimmune disease, hemoglobinopathy, hemochromatosis, sickle cell disease

    • Active or past history of calciphylaxis

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kaiser Permanente Los Angeles Medical Center Los Angeles California United States 90027

    Sponsors and Collaborators

    • Kaiser Permanente
    • Keryx Biopharmaceuticals

    Investigators

    • Principal Investigator: Victoria Kumar, MD, Kaiser Permanente

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Kaiser Permanente
    ClinicalTrials.gov Identifier:
    NCT03079869
    Other Study ID Numbers:
    • FeCitrate
    • 11035
    First Posted:
    Mar 15, 2017
    Last Update Posted:
    Jan 13, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details Study subjects who received either hemodialysis (HD) or peritoneal dialysis (PD) at Kaiser Permanente Southern California, Los Angeles Medical Center were eligible for recruitment.
    Pre-assignment Detail No pre-assignment events. 55 subjects were enrolled.
    Arm/Group Title Ferric Citrate - Hemodialysis Ferric Citrate - Peritoneal Dialysis
    Arm/Group Description Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles. Ferric Citrate: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption. Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles. Ferric Citrate: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption.
    Period Title: Overall Study
    STARTED 28 27
    COMPLETED 15 16
    NOT COMPLETED 13 11

    Baseline Characteristics

    Arm/Group Title Ferric Citrate - Hemodialysis Ferric Citrate - Peritoneal Dialysis Total
    Arm/Group Description Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles. Ferric Citrate: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption. Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles. Ferric Citrate: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption. Total of all reporting groups
    Overall Participants 21 26 47
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    65
    (13)
    57
    (14)
    60
    (14)
    Sex: Female, Male (Count of Participants)
    Female
    6
    28.6%
    7
    26.9%
    13
    27.7%
    Male
    15
    71.4%
    19
    73.1%
    34
    72.3%
    Race/Ethnicity, Customized (Count of Participants)
    Asian
    7
    33.3%
    6
    23.1%
    13
    27.7%
    African American
    6
    28.6%
    3
    11.5%
    9
    19.1%
    White
    7
    33.3%
    14
    53.8%
    21
    44.7%
    Unknown Race
    1
    4.8%
    3
    11.5%
    4
    8.5%
    Hispanic
    7
    33.3%
    12
    46.2%
    19
    40.4%
    Not Hispanic
    14
    66.7%
    13
    50%
    27
    57.4%
    Unknown Ethnicity
    0
    0%
    1
    3.8%
    1
    2.1%
    Region of Enrollment (participants) [Number]
    United States
    21
    100%
    26
    100%
    47
    100%
    Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kg/m^2]
    28.4
    (4.7)
    27.8
    (5.2)
    28.1
    (4.9)
    Smoking (Count of Participants)
    Count of Participants [Participants]
    10
    47.6%
    6
    23.1%
    16
    34%
    Duration on Dialysis (months) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [months]
    29
    (32.1)
    41.4
    (49.2)
    36.2
    (42.5)
    Diabetes (Count of Participants)
    Count of Participants [Participants]
    8
    38.1%
    7
    26.9%
    15
    31.9%
    Cerebrovascular Disease (Count of Participants)
    Count of Participants [Participants]
    6
    28.6%
    2
    7.7%
    8
    17%
    Congestive Heart Failure (Count of Participants)
    Count of Participants [Participants]
    5
    23.8%
    4
    15.4%
    9
    19.1%
    Ischemic Heart Failure (Count of Participants)
    Count of Participants [Participants]
    2
    9.5%
    2
    7.7%
    4
    8.5%
    Peripheral Vascular Disease (Count of Participants)
    Count of Participants [Participants]
    5
    23.8%
    0
    0%
    5
    10.6%

    Outcome Measures

    1. Primary Outcome
    Title Phosphorus Levels
    Description Serum phosphorus levels measured by mg/dL from the 6 months prior to enrollment were compared to serum phosphorus levels collected during the 6 months of ferric citrate use
    Time Frame 6 months

    Outcome Measure Data

    Analysis Population Description
    The final analysis included 21 Hemodialysis and 26 Peritoneal Dialysis patients after exclusion of early dropouts. Wilcoxon signed rank test was used to compare pre-treatment and on-treatment
    Arm/Group Title Ferric Citrate - Hemodialysis Ferric Citrate - Peritoneal Dialysis
    Arm/Group Description Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles. Ferric Citrate: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption. Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles. Ferric Citrate: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption.
    Measure Participants 21 26
    Pre-treatment
    5.3
    (1)
    5.6
    (0.8)
    On-treatment
    5.4
    (1.1)
    6
    (1.8)
    2. Secondary Outcome
    Title Intravenous (IV) Iron
    Description The amount of intravenous (IV) iron in mg used per month by participants for 6 months before and 6 months on Ferric Citrate treatment.
    Time Frame 6 months

    Outcome Measure Data

    Analysis Population Description
    The final analysis included 21 Hemodialysis and 26 Peritoneal Dialysis patients after exclusion of early dropouts. Wilcoxon signed rank test was used to compare pre-treatment and on-treatment.
    Arm/Group Title Ferric Citrate - Hemodialysis Ferric Citrate - Peritoneal Dialysis
    Arm/Group Description Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles. Ferric Citrate: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption. Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles. Ferric Citrate: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption.
    Measure Participants 21 26
    Pre-Treatment
    249.2
    (215.6)
    21.2
    (43.1)
    On-Treatment
    102
    (137.5)
    11.6
    (33.7)
    3. Secondary Outcome
    Title Erythropoiesis Stimulating Agents (ESA) Dose
    Description Mean Erythropoiesis Stimulating Agents (ESA) use from the 6 months prior to enrollment were compared to ESA use during the 6 months of ferric citrate use. The mean ESA dose units given to each participant per month was used in the analysis of this outcome.
    Time Frame 6 months

    Outcome Measure Data

    Analysis Population Description
    The final analysis included 21 Hemodialysis and 26 Peritoneal Dialysis patients after exclusion of early dropouts. Wilcoxon signed rank test was used to compare pre-treatment and post-treatment.
    Arm/Group Title Ferric Citrate - Hemodialysis Ferric Citrate - Peritoneal Dialysis
    Arm/Group Description Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles. Ferric Citrate: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption. Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles. Ferric Citrate: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption.
    Measure Participants 21 26
    Pre-Treatment
    28761.1
    (41314.1)
    16724.4
    (14042.3)
    Post-Treatment
    16525.8
    (16917)
    16780.1
    (13433.7)
    4. Secondary Outcome
    Title Median Pill Count
    Description median pill count of ferric citrate pills/day required to maintain phosphorus control
    Time Frame 6 months

    Outcome Measure Data

    Analysis Population Description
    The final analysis included 21 Hemodialysis and 26 Peritoneal Dialysis patients after exclusion of early dropouts.
    Arm/Group Title Ferric Citrate - Hemodialysis Ferric Citrate - Peritoneal Dialysis
    Arm/Group Description Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles. Ferric Citrate: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption. Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles. Ferric Citrate: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption.
    Measure Participants 21 26
    Phosphate binder pill count prior to Ferric Citrate use
    9.5
    6
    Phosphate binder pill count during Ferric Citrate use
    6.0
    4.5

    Adverse Events

    Time Frame 7 months
    Adverse Event Reporting Description Adverse event (AE's) were included for all patient who received study drug for at least 1 day (n=54). After the baseline visit adverse events are collected on a weekly basis for the hemodialysis patients, and on a bi-monthly basis from the dialysis patients, and again 30days after the termination of the study.
    Arm/Group Title Ferric Citrate - Hemodialysis Ferric Citrate - Peritoneal Dialysis
    Arm/Group Description Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles. Ferric Citrate: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption. Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles. Ferric Citrate: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption.
    All Cause Mortality
    Ferric Citrate - Hemodialysis Ferric Citrate - Peritoneal Dialysis
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/27 (0%) 0/27 (0%)
    Serious Adverse Events
    Ferric Citrate - Hemodialysis Ferric Citrate - Peritoneal Dialysis
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 7/27 (25.9%) 10/27 (37%)
    Blood and lymphatic system disorders
    Arteriovenous fistula 2/27 (7.4%) 2 0/27 (0%) 0
    Cardiac disorders
    Congestive heart failure exacerbation 0/27 (0%) 0 1/27 (3.7%) 1
    Gastrointestinal disorders
    gallstone pancreatitis 0/27 (0%) 0 1/27 (3.7%) 1
    Gastrointestinal Hemorrhage 1/27 (3.7%) 1 0/27 (0%) 0
    Hematochezia 1/27 (3.7%) 1 0/27 (0%) 0
    General disorders
    Abdominal swelling 0/27 (0%) 0 1/27 (3.7%) 1
    Peritonitis 0/27 (0%) 0 1/27 (3.7%) 1
    Infections and infestations
    Right foot infection 0/27 (0%) 0 1/27 (3.7%) 1
    Musculoskeletal and connective tissue disorders
    Chest pain 0/27 (0%) 0 1/27 (3.7%) 1
    Chronic back pain 1/27 (3.7%) 1 0/27 (0%) 0
    Intertrochanteric fracture 0/27 (0%) 0 1/27 (3.7%) 1
    Left foot pain 1/27 (3.7%) 1 0/27 (0%) 0
    Right hip osteoporotic Fracture 1/27 (3.7%) 1 0/27 (0%) 0
    Renal and urinary disorders
    Laparoscopic right nephrectomy 1/27 (3.7%) 1 0/27 (0%) 0
    Placement of catheter for HD 0/27 (0%) 0 1/27 (3.7%) 1
    Respiratory, thoracic and mediastinal disorders
    Pneumonia 0/27 (0%) 0 1/27 (3.7%) 1
    Right sided pleuroperitoneal leak 0/27 (0%) 0 1/27 (3.7%) 1
    Skin and subcutaneous tissue disorders
    Left heel ulcers 1/27 (3.7%) 1 0/27 (0%) 0
    Vascular disorders
    Critical limb ischemia 1/27 (3.7%) 1 0/27 (0%) 0
    Hemorrhagic cerebrovascular accident 0/27 (0%) 0 1/27 (3.7%) 1
    Peripheral vascular disease 1/27 (3.7%) 1 0/27 (0%) 0
    Other (Not Including Serious) Adverse Events
    Ferric Citrate - Hemodialysis Ferric Citrate - Peritoneal Dialysis
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 23/27 (85.2%) 27/27 (100%)
    Cardiac disorders
    Chest Pain/Palpitations 0/27 (0%) 1/27 (3.7%)
    Gastrointestinal disorders
    Black stool 20/27 (74.1%) 25/27 (92.6%)
    Diarrhea 10/27 (37%) 10/27 (37%)
    Constipation 4/27 (14.8%) 5/27 (18.5%)
    Bloating/Gas 2/27 (7.4%) 2/27 (7.4%)
    Abdominal pain 1/27 (3.7%) 2/27 (7.4%)
    Nausea, vomiting 1/27 (3.7%) 4/27 (14.8%)
    General disorders
    Peritonitis 0/27 (0%) 1/27 (3.7%)
    Fatigue 2/27 (7.4%) 0/27 (0%)
    Infections and infestations
    Abscess 0/27 (0%) 1/27 (3.7%)
    Metabolism and nutrition disorders
    Decreased appetite 0/27 (0%) 3/27 (11.1%)
    Renal and urinary disorders
    Urinary Tract Infection 1/27 (3.7%) 0/27 (0%)
    Respiratory, thoracic and mediastinal disorders
    Upper Respiratory Infection 2/27 (7.4%) 4/27 (14.8%)
    Skin and subcutaneous tissue disorders
    Itching/rash 2/27 (7.4%) 4/27 (14.8%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title KPSC PRS Administrator
    Organization Kaiser Permanente
    Phone 626-720-7463
    Email RE-CTCAT@kp.org
    Responsible Party:
    Kaiser Permanente
    ClinicalTrials.gov Identifier:
    NCT03079869
    Other Study ID Numbers:
    • FeCitrate
    • 11035
    First Posted:
    Mar 15, 2017
    Last Update Posted:
    Jan 13, 2022
    Last Verified:
    Jan 1, 2022