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An Open Label Dose Titration of Sevelamer Carbonate Tabs 3 Times a Day in Hyperphosphatemic CKD Patients Not On Dialysis

Sponsor
Genzyme, a Sanofi Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00681941
Collaborator
(none)
49
Enrollment
25
Locations
1
Arm
13.9
Duration (Months)
2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Approximately 45 hyperphosphatemic CKD patients not on dialysis will be entered into this study at approximately 20 sites within Europe and 5-10 in Australia. The purpose of this study is to determine if sevelamer carbonate tablets dosed three times a day (TID) is an effective treatment for the control of serum phosphorous levels in hyperphosphatemic CKD patients not on dialysis. Total length of participation is approximately 14 weeks.

Condition or Disease Intervention/Treatment Phase
  • Drug: Sevelamer carbonate (Renvela®)
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
49 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open Label, Dose Titration of Sevelamer Carbonate Tablets Dosed Three Times a Day in Hyperphosphatemic Chronic Kidney Disease Patients Not On Dialysis
Study Start Date :
Jan 1, 2006
Actual Primary Completion Date :
Jan 1, 2007
Actual Study Completion Date :
Mar 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Sevelamer Carbonate Tablets Dosed Three Times A Day

Drug: Sevelamer carbonate (Renvela®)
Sevelamer Carbonate Tablets Dosed Three Times A Day

Outcome Measures

Primary Outcome Measures

  1. Evaluate the efficacy of sevelamer carbonate tablets dosed three times per day (TID) with meals on control of serum phosphorus levels [Up to day 70]

  2. Evaluate the safety and tolerability of sevelamer carbonate tablets dosed TID with meals. [Up to day 70]

Secondary Outcome Measures

  1. Serum calcium-phosphorus product [Up to day 70]

  2. Serum lipid profile [total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol] [Up to day 70]

  3. Percent responders [serum phosphorus between 2.7 and 4.6 mg/dL (0.87 and 1.49 mmol/L) inclusive] at Day 56/ET [Up to day 70]

Eligibility Criteria

Criteria

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

  • A minimum of 120 male and female patients with chronic kidney disease not requiring dialysis will be screened for participation in the study.

  • Men or woman 18 years of age or older

  • If currently taking phosphate binder(s), willing to stop this and enter a 2 week washout period

  • Willing to avoid any intentional changes in diet such as fasting or dieting

  • Have the following central laboratory measurements: 1. If not on a phosphate binder, a serum phosphorus measurement ≥ 5.5 mg/dL (1.76 mmol/L) at Screening (Visit1). 2. If taking a phosphate binder(s) at screening, a serum phosphorus measurement ≥ 5.5 mg/dL (1.76 mmol/L) after the two-week washout period at Visit 1a (Day 0).

  • At Screening (Visit 1), have the following central laboratory measurements: 1. 25-hydroxyvitamin D ≥ 10 ng/mL 2. iPTH ≤ 800 pg/mL

  • Willing and able to take sevelamer carbonate alone as a phosphate binder for the duration of the study

  • Willing and able to maintain screening doses of lipid medication, 1,25 dihydroxyvitamin D, and/or cinacalcet for the duration of the study, except for safety reasons

  • Willing and able to avoid antacids and phosphate binders containing aluminum, magnesium, calcium or lanthanum for the duration of the study unless prescribed as an evening calcium supplement

  • If female and of childbearing potential (pre-menopausal and not surgically sterile), willing to use an effective contraceptive method throughout study, which includes barrier methods, hormones, or IUDs

  • Expecting not to initiate dialysis for the duration of this study

  • Considered compliant with phosphate binders (if applicable)

  • Willing and able to provide informed consent

  • Has not participated in any other investigational drug studies within 30 days prior to enrollment,

  • Level of understanding and willingness to cooperate with all visits and procedures as described by the study personnel

Exclusion Criteria:

  • Active bowel obstruction, dysphagia, swallowing disorder or severe gastrointestinal (GI) motility disorders

  • Active ethanol or drug abuse, excluding tobacco use

  • Use of anti-arrhythmic or anti-seizure medications for arrhythmia or seizure disorders.

  • In the opinion of the investigator, patient has poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, HIV infection, or any clinically significant unstable medical condition

  • Pregnant or breast-feeding

  • Evidence of active malignancy except for basal cell carcinoma of the skin

  • Unable to comply with the requirements of the study

  • Known hypersensitivity to sevelamer or any constituents of the study drug

  • Any other condition, which in the opinion of the investigator will prohibit the patient's inclusion in the study

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nephrology Department, Princess Alexandra Hospital Wooloongabba Queensland Australia 4102
2 Renal Unit, The Queen Elizabeth Hospital Woodville South Australia Australia 5011
3 Renal Research Unit, Launceston General Hospital Launceston Tasmania Australia 7250
4 The Royal Melbourne Hospital, Department of Nephrology Parkville Victoria Australia 3050
5 Melbourne Renal Research Group, Epworth Medical Centre Richmond Victoria Australia 3121
6 Nyremedicinsk Afdeling, Medicinerhuset Aalborg Denmark DK-9100
7 Nefrologisk Afdeling, Hilleroed Sygehus Hilleroed Denmark DK 3400
8 Medicinsk Afdeling København Denmark DK-2100
9 Medicinsk Afdeling, nefrologisk, Roskilde Sygehus Roskilde Denmark DK-4000
10 George Pompidou, European Hospital Paris France 75908
11 Universitätsklinikum Aachen, Medizinsche Klinik II Aachen Germany D-52074
12 Universitätsklinikum Hamburg Eppendorf Hamburg Germany D-20246
13 Heimdialysezentrum Heidelberg Germany D-69115
14 KfH Nierenzentrum Nürnberg Germany D-90431
15 Stadt Klinken Solingen, Klinik für Nephrologie und Allgemeine Innere Medizin Solingen Germany D 42653
16 Nephrologisches Zentrum Villingen-Schwenningen Germany D 78054
17 Birmingham Hospital, Queen Elizabeth Medical Centre Birmingham England United Kingdom B15 2PR
18 Southmead Hospital Bristol England United Kingdom BS10 5NB
19 Addenbrooke's Dialysis Centre Cambridge England United Kingdom CB2 2QQ
20 Leicester General Hospital Leicester England United Kingdom LE5 4PW
21 Renal Department, The Royal London Hospital London England United Kingdom E1 1BB
22 Renal & Urology SDU Offices London England United Kingdom SE1 9RT
23 Renal Dialysis Unit, Manchester Royal Infirmary Manchester England United Kingdom M13 9WL
24 Department of Renal Medicine, Hope Hospital Manchester England United Kingdom M6 8HD
25 Renal Unit, Queen Alexandra Hospital Portsmouth England United Kingdom PO6 3RY

Sponsors and Collaborators

  • Genzyme, a Sanofi Company

Investigators

  • Study Director: Medical Monitor, Genzyme, a Sanofi Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00681941
Other Study ID Numbers:
  • SVCARB00105
  • ACTRN012606000380594
First Posted:
May 21, 2008
Last Update Posted:
Mar 20, 2015
Last Verified:
Mar 1, 2015
Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Hyperphosphatemia
Sevelamer

Study Results

No Results Posted as of Mar 20, 2015