Randomized Study Comparing Genz-644470, Placebo, and Sevelamer Carbonate in Chronic Kidney Disease Patients on Hemodialysis (LEAP)
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| ClinicalTrials.gov Identifier: NCT00853242 |
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Recruitment Status :
Completed
First Posted : March 2, 2009
Results First Posted : May 1, 2015
Last Update Posted : May 1, 2015
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Sponsor:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
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Brief Summary:
The purpose of this clinical study is to compare the effects of Genz-644470 with the effects of placebo and sevelamer carbonate (Renvela®) on the reduction of serum phosphorus in hyperphosphatemic chronic kidney disease participants on hemodialysis.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Kidney Failure, Chronic | Drug: Placebo Drug: Genz-644470 Drug: Sevelamer carbonate | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 349 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study Using Genz-644470 and Sevelamer Carbonate in Hyperphosphatemic Chronic Kidney Disease Patients on Hemodialysis |
| Study Start Date : | February 2009 |
| Actual Primary Completion Date : | August 2009 |
| Actual Study Completion Date : | August 2009 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Placebo
Placebo matched to Genz-644470 tablet orally three times a day (TID) with meals for 3 weeks.
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Drug: Placebo |
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Experimental: Genz-644470 2.4 Grams Per Day (g/day)
Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
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Drug: Genz-644470 |
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Experimental: Genz-644470 4.8 g/day
Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
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Drug: Genz-644470 |
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Experimental: Genz-644470 7.2 g/day
Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
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Drug: Genz-644470 |
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Active Comparator: Sevelamer Carbonate 2.4 g/day
Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
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Drug: Sevelamer carbonate
Other Name: Renvela® |
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Active Comparator: Sevelamer Carbonate 4.8 g/day
Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
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Drug: Sevelamer carbonate
Other Name: Renvela® |
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Active Comparator: Sevelamer Carbonate 7.2 g/day
Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
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Drug: Sevelamer carbonate
Other Name: Renvela® |
Primary Outcome Measures :
- Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Placebo) [ Time Frame: Baseline, Day 22 ]
Secondary Outcome Measures :
- Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Sevelamer Carbonate) [ Time Frame: Baseline, Day 22 ]
- Change From Baseline in Serum Calcium (Albumin-adjusted)-Phosphorus Product at Week 22 [ Time Frame: Baseline, Day 22 ]
- Change From Baseline in Total Cholesterol at Day 22 [ Time Frame: Baseline, Day 22 ]
- Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol at Day 22 [ Time Frame: Baseline, Day 22 ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Serum phosphate level greater than (>) 5.5 milligram per deciliter (mg/dL) (1.78 millimole per liter [mmol/L]) after discontinuation of current phosphate binder therapy
- Men or women 18 years or older
Exclusion Criteria:
- Have active dysphagia or swallowing disorder or a predisposition to or current bowel obstruction, ileus, or severe gastrointestinal motility disorders including severe constipation
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00853242
Locations
Show 53 study locations
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
| Study Director: | Medical Monitor | Genzyme, a Sanofi Company |
| Responsible Party: | Genzyme, a Sanofi Company |
| ClinicalTrials.gov Identifier: | NCT00853242 |
| Other Study ID Numbers: |
APB00108 |
| First Posted: | March 2, 2009 Key Record Dates |
| Results First Posted: | May 1, 2015 |
| Last Update Posted: | May 1, 2015 |
| Last Verified: | April 2015 |
Keywords provided by Sanofi ( Genzyme, a Sanofi Company ):
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Chronic Kidney Disease Phosphate Binder Phosphate Hyperphosphatemia |
Additional relevant MeSH terms:
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Kidney Diseases Renal Insufficiency, Chronic Renal Insufficiency Kidney Failure, Chronic Urologic Diseases |
Sevelamer Chelating Agents Sequestering Agents Molecular Mechanisms of Pharmacological Action |