- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03001011
Evaluation of Renvela in Patients With Chronic Kidney Disease Not On Dialysis And Hyperphosphatemia In China (RECOVER)
A 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
Primary Objective:
To demonstrate efficacy of Renvela tablets in the reduction of serum phosphorus in hyperphosphatemia in participants 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 participants reaching the target serum phosphorus level 4.6 milligrams per decilitre (mg/dL) (1.47 millimoles per litre [mmol/L], inclusive).
To evaluate safety of Renvela tablets.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
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Beijing, China, 100034
- Investigational Site Number 1560003
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Cangzhou, China, 061000
- Investigational Site Number 1560026
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Changchun, China, 130021
- Investigational Site Number 1560015
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Changsha, China, 410011
- Investigational Site Number 1560011
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Chongqing, China, 400038
- Investigational Site Number 1560030
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Dalian, China, 116011
- Investigational Site Number 1560019
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Fuzhou, China, 350005
- Investigational Site Number 1560013
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Guangzhou, China, 510080
- Investigational Site Number 1560001
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Guangzhou, China, 510120
- Investigational Site Number 1560027
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Guilin, China
- Investigational Site Number 1560037
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Haikou, China, 570311
- Investigational Site Number 1560031
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Hengyang, China, 421001
- Investigational Site Number 1560036
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Hengyang, China, 421001
- Investigational Site Number 1560039
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Hohhot, China, 010050
- Investigational Site Number 1560023
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Kunming, China
- Investigational Site Number 1560033
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Kunming, China
- Investigational Site Number 1560034
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Lanzhou, China, 730030
- Investigational Site Number 1560006
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Nanchang, China, 330006
- Investigational Site Number 1560004
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Nanchang, China, 330006
- Investigational Site Number 1560005
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Nanchang, China, 330006
- Investigational Site Number 1560032
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Nanjing, China, 210011
- Investigational Site Number 1560017
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Nanning, China
- Investigational Site Number 1560029
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Ningbo, China
- Investigational Site Number 1560028
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Shanghai, China, 200025
- Investigational Site Number 1560002
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Shanghai, China, 200072
- Investigational Site Number 1560007
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Shenyang, China, 110004
- Investigational Site Number 1560021
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Shenyang, China, 110016
- Investigational Site Number 1560038
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Shijiazhuang, China, 050000
- Investigational Site Number 1560025
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Taiyuan, China, 030001
- Investigational Site Number 1560022
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Tianjin, China, 300052
- Investigational Site Number 1560012
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Tianjin, China, 300121
- Investigational Site Number 1560014
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Wuhan, China, 430030
- Investigational Site Number 1560010
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Xi'An, China, 710061
- Investigational Site Number 1560008
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Xiamen, China, 361003
- Investigational Site Number 1560020
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Xiamen, China, 361004
- Investigational Site Number 1560018
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Xuzhou, China, 221002
- Investigational Site Number 1560035
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Yinchuan, China, 750004
- Investigational Site Number 1560024
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Zhanjiang, China, 524001
- Investigational Site Number 1560016
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- Participants with chronic kidney disease who had not been on dialysis, and were not expected to begin dialysis, or renal transplantation in the next 4 months from the screening visit.
- Had serum phosphorus measurement greater than or equal to (>=) 5.5 mg/dL (1.78 mmol/L) at screening visit (if participants were not on phosphate binder[s] at Screening Visit) OR at the end of Washout Period (if participants were on phosphate binder[s] at screening visit).
Had the following laboratory measurements at screening visit:
- 25-hydroxy vitamin D >=10 nanograms per milliliter (ng/mL).
- intact parathyroid hormone, intact parathyroid hormone (iPTH) <=800 picograms per millilitre (pg/mL).
- Signed written informed consent.
Exclusion criteria:
- Men or women below 18 years of age.
- Any technical/administrative reason that made it impossible to randomize the participant in the study.
- Was 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.
- Had participated in any other investigational drug studies within 30 days, or 5 half lives, whichever is longer, prior to screening visit.
Conditions/situations such as:
- Participant was the Investigator or any Subinvestigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
- Uncooperative or any condition that could make the participant potentially non-compliant to the study procedures (for example, participants could not be contacted by phones as required in phone call visits).
- Evidence of active malignancy.
- Not on stable medical condition (for example, but not limited to, active ethanol or drug abuse [tobacco use acceptable]; documented poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, human immunodeficiency virus [HIV] infection), or had any clinically significant medical conditions.
- Had known hypersensitivity to sevelamer or any constituents of Renvela tablets.
- Had 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.
- Was pregnant or breast-feeding.
- If the participant was female, and of childbearing potential (pre-menopausal and not surgically sterile), was not willing to use an effective contraceptive method throughout the study.
- Had any condition, which in the opinion of the investigator would prohibit the participant's inclusion in the study.
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Participants received placebo (for Renvela) orally 3 times per day (TID) for up to 8 weeks.
One to five tablets were taken with meals, as directed by physician and were titrated (up to a maximum of 15 tablets per day) to reach a target goal of serum phosphorus less than or equal to (<=) 4.6 mg/dL (<=1.49
mmol/L).
|
Pharmaceutical form: tablet Route of administration: oral |
Experimental: Renvela
Participants received Renvela orally TID for up to 8 weeks.
One to five tablets were taken with meals, as directed by physician and were titrated (up to a maximum of 15 tablets per day) to reach a target goal of serum phosphorus <=4.6 mg/dL (<=1.49
mmol/L).
|
Pharmaceutical form: tablet Route of administration: oral
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Serum Phosphorus at Week 8
Time Frame: Baseline, Week 8
|
Baseline of serum phosphorus value was the last serum phosphorus level obtained before the first double-blind investigational medicinal product (IMP) dosing.
Missing Week 8 data were imputed by last observation carried forward [LOCF] method.
|
Baseline, Week 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Total Cholesterol at Week 8
Time Frame: Baseline, Week 8
|
Missing Week 8 data were imputed by LOCF method.
|
Baseline, Week 8
|
Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 8
Time Frame: Baseline, Week 8
|
Missing Week 8 data were imputed by LOCF method.
|
Baseline, Week 8
|
Change From Baseline in Calcium-Phosphorus Product at Week 8
Time Frame: Baseline, Week 8
|
Missing Week 8 data were imputed by LOCF method.
|
Baseline, Week 8
|
Change From Baseline in Intact Parathyroid Hormone (Ipth) Level at Week 8
Time Frame: Baseline, Week 8
|
Missing Week 8 data were imputed by LOCF method.
|
Baseline, Week 8
|
Percentage of Participants Reaching the Target Serum Phosphorus Level (4.6 mg/dL [1.49 mmol/L]) at Week 8
Time Frame: Week 8
|
Missing Week 8 data were imputed by LOCF method.
|
Week 8
|
Change From Baseline in Serum Phosphorus Level at Week 4
Time Frame: Baseline, Week 4
|
Missing Week 4 data were imputed by LOCF method.
|
Baseline, Week 4
|
Number of Participants With Treatment Emergent Adverse Event
Time Frame: From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59
|
Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an Adverse Event (AE) without regard to possibility of causal relationship with this treatment.
Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during TEAE period.
On-treatment period was defined as the (time from the first dose of IMP to the last dose of IMP+3 days).
A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event.
Any TEAE included participants with both serious and non-serious AEs.
|
From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters
Time Frame: From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59
|
Criteria for potentially clinically significant abnormalities:
|
From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Metabolic Parameters
Time Frame: From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59
|
Criteria for potentially clinically significant abnormalities:
|
From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Electrolytes
Time Frame: From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59
|
Criteria for potentially clinically significant abnormalities: Sodium: <=129 millimoles (mmol)/L; >=160 mmol/L Potassium: <3 mmol/L; >=5.5 mmol/L Chloride: <80 mmol/L; >115 mmol/L. |
From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Renal Function Parameters
Time Frame: From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59
|
Criteria for potentially clinically significant abnormalities: Creatinine: >=150 micromol/L; >=30% change from baseline, >=100% change from baseline Creatinine clearance: <15 mL/min; >=15 to <30 mL/min; >=30 to <60 mL/min; >=60 to <90 mL/min Blood urea nitrogen: >=17 mmol/L Uric acid: <120 micromol/L; >408 micromol/L Glomular Filtration Rate (GFR): < 15 mL/min/1.73m^2, >= 15 - < 30 mL/min/1.73m^2, >= 30 - < 60 mL/min/1.73m^2, >= 60 - < 90 mL/min/1.73m^2. |
From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Liver Function Parameters
Time Frame: From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59
|
Criteria for potentially clinically significant abnormalities: Alanine Aminotransferase (ALT): >3 ULN; >5 ULN; >10 ULN; Aspartate aminotransferase (AST): >3 ULN. |
From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59
|
Number of Participants With Clinically Significant Vital Signs Abnormalities
Time Frame: From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59
|
Criteria for potentially clinically significant vital sign abnormalities: Systolic blood pressure (SBP) supine: <=95 millimeters of mercury (mmHg) and DFB >=20 mmHg; >=160 mmHg and increase from baseline (IFB) >=20 mmHg Diastolic blood pressure (DBP) supine: <=45 mmHg and DFB >=10 mmHg; >=110 mmHg and IFB >=10 mmHg Heart rate (HR) supine: <=50 beats per minute (bpm) and DFB >=20 bpm; >=120 bpm and IFB >=20 bpm Weight: >=5% DFB; >=5% IFB. |
From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EFC14011
- U1111-1161-9850 (Other Identifier: UTN)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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