Evaluation of Renvela in Patients With Chronic Kidney Disease Not On Dialysis And Hyperphosphatemia In China

ID: NCT03001011
Status: Recruiting
Phase: Phase 3
Start Date: June 07, 2017
First Submitted: December 20, 2016
Last Updated: February 22, 2018
Results: N/A
Organization: Sanofi
Sponsors & Collaborators: Sanofi
Location: China
Conditions: Hyperphosphatemia
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Study Description

Brief Summary

Primary Objective:

To demonstrate efficacy of Renvela tablets in the reduction of serum phosphorus in hyperphosphatemia in patients with chronic kidney disease not on dialysis.

Secondary Objectives:

To document the efficacy of Renvela tablets in the reduction of serum lipids (total cholesterol and low-density lipoprotein cholesterol [LDL-C]) To document the efficacy of Renvela tablets in the reduction of calcium-phosphorus product.

To document the efficacy of Renvela tablets in the reduction of intact parathyroid hormone (iPTH).

To document the efficacy of Renvela tablets in proportion of patients reaching the target serum phosphorus level (4.6 mg/dL [1.47 mmol/L], inclusive).

To evaluate safety of Renvela tablets.

Detailed Description

The total duration of study period per patient will be up to 14 weeks.
Condition or disease Intervention/treatment Phase

Hyperphosphatemia

Drug: Placebo
Other Names
Drug: Sevelamer Carbonate (GZ419831)
Other Names
Renvela
Phase 3

Tracking Information

First Submitted DateDecember 20, 2016
Last Update Posted DateFebruary 22, 2018
Actual Start DateJune 07, 2017
Anticipated Completion DateAugust 01, 2018
Actual Primary Completion DateAugust 01, 2018
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Change from baseline in serum phosphorus level [Time Frame: at Week 8]

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Change from baseline in total cholesterol [Time Frame: at Week 8]

  • Change from baseline in LDL-C [Time Frame: at Week 8]

  • Change from baseline in calcium-phosphorus product [Time Frame: at Week 8]

  • Change from baseline in intact parathyroid hormone (iPTH) level [Time Frame: at Week 8]

  • Percentage of patients reaching the target serum phosphorus level (4.6 mg/dL [1.47 mmol/L], inclusive) [Time Frame: at Week 8]

  • Change from baseline in serum phosphorus level [Time Frame: at Week 4]

  • Proportion of patients with adverse events [Time Frame: up to 8 weeks]

  • Clinically significant changes in vital signs and clinical laboratory parameters (hematology, clinical chemistry, and lipid panel) [Time Frame: up to 8 weeks]

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleEvaluation of Renvela in Patients With Chronic Kidney Disease Not On Dialysis And Hyperphosphatemia In China
Official TitleA Randomized, Double Blind, Parallel Group Study For Assessing The Efficacy And Safety Of Renvela® Tablets For The Treatment Of Hyperphosphatemia In Patients With Chronic Kidney Disease Not On Dialysis Versus Placebo
Brief Summary

Primary Objective:

To demonstrate efficacy of Renvela tablets in the reduction of serum phosphorus in hyperphosphatemia in patients with chronic kidney disease not on dialysis.

Secondary Objectives:

To document the efficacy of Renvela tablets in the reduction of serum lipids (total cholesterol and low-density lipoprotein cholesterol [LDL-C]) To document the efficacy of Renvela tablets in the reduction of calcium-phosphorus product.

To document the efficacy of Renvela tablets in the reduction of intact parathyroid hormone (iPTH).

To document the efficacy of Renvela tablets in proportion of patients reaching the target serum phosphorus level (4.6 mg/dL [1.47 mmol/L], inclusive).

To evaluate safety of Renvela tablets.

Detailed Description

The total duration of study period per patient will be up to 14 weeks.

Study TypeInterventional
Study PhasePhase 3
Estimated Enrollment
202
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Quadruple
Primary Purpose
Treatment
Conditions
Hyperphosphatemia
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: Placebo

Pharmaceutical form: tablet Route of administration: oral

Other Names
Drug: Sevelamer Carbonate (GZ419831)

Pharmaceutical form: tablet Route of administration: oral

Other Names
Renvela
Study Groups/Cohorts
Renvela
oral tablets with meal, three times a day

Placebo
oral tablets with meal, three times a day

Study Arms
Placebo Comparator Placebo
oral tablets with meal, three times a day
Drug : Placebo
Pharmaceutical form: tablet Route of administration: oral

Experimental Renvela
oral tablets with meal, three times a day
Drug : Sevelamer Carbonate (GZ419831)
Pharmaceutical form: tablet Route of administration: oral

Arm Intervention/Treatment
Placebo Comparator Placebo
oral tablets with meal, three times a day
Drug : Placebo
Experimental Renvela
oral tablets with meal, three times a day
Drug : Sevelamer Carbonate (GZ419831)

Recruitment Information

Recruitment Status:Recruiting
Enrollment202
Completion DateAugust 01, 2018
Eligibility Criteria: Inclusion criteria:
- Patients with chronic kidney disease who have not been on dialysis, and are not expected to begin dialysis, or renal transplantation in the next 4 months from the screening visit.
- Have serum phosphorus measurement ≥5.5 mg/dL (1.78 mmol/L) at Screening Visit (if patients are not on phosphate binder[s] at Screening Visit) OR at the end of Washout Period (if patients are on phosphate binder[s] at Screening Visit).
- Have the following laboratory measurements at Screening Visit:
- 25-hydroxy vitamin D ≥10 ng/mL.
- iPTH ≤800 pg/mL.
- Willing and able to sign written informed consent.
Exclusion criteria:
- Men or women below 18 years of age.
- Is not of the level of understanding and willingness to cooperate with all visits and procedures, as described in the study protocol.
- Not yet received chronic kidney disease diet education before screening visit.
- Not willing and not able to avoid changes to diet during the study.
- Not willing or able to maintain screening doses of lipid lowering medication, 1, 25 dihydroxy vitamin D, and/or cinacalcet for the duration of the study, except for safety reasons.
- Not willing or not able to avoid antacids and phosphate binders containing aluminium, magnesium, calcium, or lanthanum for the duration of the study unless prescribed as an evening calcium supplement.
- Have participated in any other investigational drug studies within 30 days, or 5 half lives, whichever is longer, prior to screening visit.
- Have known hypersensitivity to sevelamer or any constituents of Renvela tablets.
- Have bowel obstruction, active dysphagia or swallowing disorder, or a predisposition to or current bowel obstruction, ileus, or severe gastrointestinal motility disorders including severe constipation.
- Using or plan to use anti-arrhythmic or anti-seizure medications for arrhythmia or seizure disorders.
- Is pregnant or breast-feeding.
- If the patient is female, and of childbearing potential (pre-menopausal and not surgically sterile), is not willing to use an effective contraceptive method throughout the study.
- Have any condition, which in the opinion of the investigator would prohibit the patient's inclusion in the study.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
China

Administrative Information

NCT Number:NCT03001011
Other Study ID Numbers
EFC14011
U1111-1161-9850
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Sanofi
Collaborators
Not Available
Investigators
Study Director
Clinical Sciences & Operations
Sanofi