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

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
sevelamer carbonate (Renvela®) sevelamer hydrochloride (Renagel ®)
sevelamer hydrochloride (Renagel ®) sevelamer carbonate (Renvela®)
Sponsored by
Genzyme, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Hemodialysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: 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 An most recent iPTH measurement ≤ 900 pg/mL (< 99 pmol/L) within 90 days of screening 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: A serum phosphorus measurement ≥ 5.5 mg/dL (≥ 1.76 mmol/L) at Visit 2 (after Washout) A serum iPTH measurement ≤ 800 pg/mL at Visit 5 (prior to randomization) 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.

Sites / Locations

  • Southmead Hospital
  • Addenbrooks NHS Trust
  • The Royal London Hospital
  • Guy's Hospital
  • Manchester Royal Infirmary
  • Hope Hospital
  • Norfolk and Norwich University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

1

2

Arm Description

sevelamer carbonate powder x 4 weeks then, sevelamer hydrochloride x 4 weeks

sevelamer hydrochloride x 4 weeks then, sevelamer carbonate powder x 4 weeks

Outcomes

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
Evaluate the safety and tolerability of sevelamer carbonate powder compared to sevelamer hydrochloride tablets dosed TID with meals

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
serum lipid profile (total cholesterol, high density lipoprotein [HDL] and low density lipoprotein [LDL] and triglycerides)

Full Information

First Posted
December 20, 2005
Last Updated
March 17, 2015
Sponsor
Genzyme, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00267514
Brief Title
Study to Demonstrate Equivalence of Sevelamer Carbonate Powder and Sevelamer HCl Tablets in Haemodialysis Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Genzyme, a Sanofi Company

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
Hemodialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
sevelamer carbonate powder x 4 weeks then, sevelamer hydrochloride x 4 weeks
Arm Title
2
Arm Type
Other
Arm Description
sevelamer hydrochloride x 4 weeks then, sevelamer carbonate powder x 4 weeks
Intervention Type
Drug
Intervention Name(s)
sevelamer carbonate (Renvela®) sevelamer hydrochloride (Renagel ®)
Intervention Description
sevelamer carbonate powder dosed TID with meals for four weeks followed by sevelamer hydrochloride tablets dosed TID with meals for four weeks
Intervention Type
Drug
Intervention Name(s)
sevelamer hydrochloride (Renagel ®) sevelamer carbonate (Renvela®)
Intervention Description
sevelamer hydrochloride tablets dosed TID with meals for four weeks followed by sevelamer carbonate powder dosed TID with meals for four weeks
Primary Outcome Measure Information:
Title
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
Title
Evaluate the safety and tolerability of sevelamer carbonate powder compared to sevelamer hydrochloride tablets dosed TID with meals
Time Frame
Up to 13 weeks
Secondary Outcome Measure Information:
Title
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
Title
serum lipid profile (total cholesterol, high density lipoprotein [HDL] and low density lipoprotein [LDL] and triglycerides)
Time Frame
Up to 13 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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 An most recent iPTH measurement ≤ 900 pg/mL (< 99 pmol/L) within 90 days of screening 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: A serum phosphorus measurement ≥ 5.5 mg/dL (≥ 1.76 mmol/L) at Visit 2 (after Washout) A serum iPTH measurement ≤ 800 pg/mL at Visit 5 (prior to randomization) 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Genzyme, a Sanofi Company
Official's Role
Study Director
Facility Information:
Facility Name
Southmead Hospital
City
Bristol
ZIP/Postal Code
BS10 5NB
Country
United Kingdom
Facility Name
Addenbrooks NHS Trust
City
Cambridge
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
The Royal London Hospital
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
Guy's Hospital
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Manchester Royal Infirmary
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
Hope Hospital
City
Manchester
ZIP/Postal Code
M6 8HD
Country
United Kingdom
Facility Name
Norfolk and Norwich University Hospital
City
Norwich
ZIP/Postal Code
NR4 7UY
Country
United Kingdom

12. IPD Sharing Statement

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

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