Study to Demonstrate Equivalence of Sevelamer Carbonate Powder and Sevelamer HCl Tablets in Haemodialysis Patients

This study has been completed.
Sponsor:
Information provided by:
Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT00267514
First received: December 20, 2005
Last updated: August 3, 2009
Last verified: May 2007
  Purpose

The purpose of this study is to determine if sevelamer carbonate powder is an effective treatment for the control of serum phosphorous levels in patients on dialysis when compared to sevelamer hydrochloride tablets.


Condition Intervention Phase
Chronic Kidney Disease
Drug: sevelamer carbonate (Renvela®) sevelamer hydrochloride (Renagel ®)
Drug: sevelamer hydrochloride (Renagel ®) sevelamer carbonate (Renvela®)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Cross-over Study to Demonstrate Equivalence of Sevelamer Carbonate Powder and Sevelamer Hydrochloride Tablets Dosed Three Times Per Day in Haemodialysis Patients

Resource links provided by NLM:


Further study details as provided by Genzyme, a Sanofi Company:

Primary Outcome Measures:
  • Demonstrate the equivalence of sevelamer carbonate powder to sevelamer hydrochloride tablets dosed three times per day (TID) with meals on the control of serum phosphorus levels [ Time Frame: Up to 13 weeks ] [ Designated as safety issue: No ]
  • Evaluate the safety and tolerability of sevelamer carbonate powder compared to sevelamer hydrochloride tablets dosed TID with meals [ Time Frame: Up to 13 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Compare the effects of sevelamer carbonate powder to sevelamer hydrochloride tablets when dosed three times a day with meals on: serum calcium-phosphorus product [ Time Frame: Up to 13 weeks ] [ Designated as safety issue: No ]
  • serum lipid profile (total cholesterol, high density lipoprotein [HDL] and low density lipoprotein [LDL] and triglycerides) [ Time Frame: Up to 13 weeks ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: January 2006
Study Completion Date: May 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
sevelamer carbonate powder x 4 weeks then, sevelamer hydrochloride x 4 weeks
Drug: sevelamer carbonate (Renvela®) sevelamer hydrochloride (Renagel ®)
sevelamer carbonate powder dosed TID with meals for four weeks followed by sevelamer hydrochloride tablets dosed TID with meals for four weeks
2
sevelamer hydrochloride x 4 weeks then, sevelamer carbonate powder x 4 weeks
Drug: sevelamer hydrochloride (Renagel ®) sevelamer carbonate (Renvela®)
sevelamer hydrochloride tablets dosed TID with meals for four weeks followed by sevelamer carbonate powder dosed TID with meals for four weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Receiving three times per week haemodialysis for three months or longer.
  • Taking sevelamer hydrochloride alone (e.g. not using other types of phosphate binders concomitantly) or on combination therapy (e.g. using sevelamer hydrochloride and calcium containing, or metal phosphate binders concomitantly) not exceeding a total daily binder dose of 14.4 g, for at least 60 days prior to screening.
  • Have the following documented local laboratory measurements:

    1. Two most recent consecutive serum phosphorus measurements that are ≥ 3.0 and ≤ 7.0 mg/dL (≥ 0.96 and ≤ 2.26 mmol/L) within 60 days of screening
    2. An most recent iPTH measurement ≤ 900 pg/mL (< 99 pmol/L) within 90 days of screening
    3. A most recent serum calcium (adjusted for albumin) measurement within normal range defined by the local laboratory within 60 days of screening
  • Have the following central laboratory measurements:

    1. A serum phosphorus measurement ≥ 5.5 mg/dL (≥ 1.76 mmol/L) at Visit 2 (after Washout)
    2. A serum iPTH measurement ≤ 800 pg/mL at Visit 5 (prior to randomization)
    3. A serum phosphorus measurement ≥ 3.0 and ≤ 6.5 mg/dL (≥ 0.96 and ≤ 2.08 mmol/L) at Visit 5
  • If on vitamin D replacement or calcimimetics therapy, be at a stable dose for at least one month prior to screening and willing to maintain the same dose throughout the duration of the study, except for safety reasons.
  • Willing to maintain screening doses of lipid medication for the duration of the study, except for safety reasons.
  • Willing to avoid any intentional changes in diet such as fasting or dieting.
  • 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 intrauterine devices (IUDs).
  • Willing to stop all calcium supplements not prescribed by the investigator including multivitamins containing calcium.
  • Willing to refrain from using aluminium, calcium, lanthanum, or magnesium containing antacids throughout duration of the study unless prescribed by the investigator as a calcium supplement per protocol.
  • Have a level of understanding and willingness to cooperate with all visits and procedures, including telephone contacts, as described in the consent by the study site personnel.

Exclusion Criteria:

  • Have poorly controlled diabetes mellitus or hypertension, active vasculitis, HIV infection, or any clinically significant unstable medical condition (defined by investigator).
  • Have active dysphagia, swallowing disorders, bowel obstruction, or severe gastrointestinal motility disorders.
  • Have participated in a study of an investigational drug during the 30 days preceding the start of the screening period.
  • Has active ethanol or drug dependence or abuse, excluding tobacco use.
  • Have any other condition, which, in the investigator's opinion, will prohibit the patient's participation in the study.
  • If female, be pregnant or breast-feeding.
  • Have any evidence of active malignancy except for basal cell carcinoma of the skin. A history of malignancy is not an exclusion.
  • Use of anti-arrhythmic or anti-seizure medications for arrhythmia or seizure disorders.
  • Have a known hypersensitivity to sevelamer or any of its constituents.
  • Have a poor record of compliance with medication.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00267514

Locations
United Kingdom
Southmead Hospital
Bristol, United Kingdom, BS10 5NB
Addenbrooks NHS Trust
Cambridge, United Kingdom, CB2 2QQ
Guy's Hospital
London, United Kingdom, SE1 9RT
The Royal London Hospital
London, United Kingdom, E1 1BB
Hope Hospital
Manchester, United Kingdom, M6 8HD
Manchester Royal Infirmary
Manchester, United Kingdom, M13 9WL
Norfolk and Norwich University Hospital
Norwich, United Kingdom, NR4 7UY
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

No publications provided

Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00267514     History of Changes
Other Study ID Numbers: SVCARB00205
Study First Received: December 20, 2005
Last Updated: August 3, 2009
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Genzyme, a Sanofi Company:
Hemodialysis

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency
Sevelamer
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014