Clinical trial NCT03001011: Evaluation of Renvela in Patients With Chronic Kidney Disease Not On Dialysis And Hyperphosphatemia In China
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperphosphatemia
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2016-12-22
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The total duration of study period per participant was up to 14 weeks.

Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Serum Phosphorus at Week 8
timeFrame: Baseline, Week 8
Secondary outcomes:
measure: Change From Baseline in Total Cholesterol at Week 8
timeFrame: Baseline, Week 8
measure: Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 8
timeFrame: Baseline, Week 8
measure: Change From Baseline in Calcium-Phosphorus Product at Week 8
timeFrame: Baseline, Week 8
measure: Change From Baseline in Intact Parathyroid Hormone (Ipth) Level at Week 8
timeFrame: Baseline, Week 8
measure: Percentage of Participants Reaching the Target Serum Phosphorus Level (4.6 mg/dL [1.49 mmol/L]) at Week 8
timeFrame: Week 8
measure: Change From Baseline in Serum Phosphorus Level at Week 4
timeFrame: Baseline, Week 4
measure: Number of Participants With Treatment Emergent Adverse Event
timeFrame: From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59
measure: Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters
timeFrame: From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59
measure: Number of Participants With Clinically Significant Laboratory Abnormalities: Metabolic Parameters
timeFrame: From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59
measure: Number of Participants With Clinically Significant Laboratory Abnormalities: Electrolytes
timeFrame: From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59
measure: Number of Participants With Clinically Significant Laboratory Abnormalities: Renal Function Parameters
timeFrame: From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59
measure: Number of Participants With Clinically Significant Laboratory Abnormalities: Liver Function Parameters
timeFrame: From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59
measure: Number of Participants With Clinically Significant Vital Signs Abnormalities
timeFrame: From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59
Other outcomes:
Locations:
city: Beijing
country: China
facility: Investigational Site Number 1560003
city: Cangzhou
country: China
facility: Investigational Site Number 1560026
city: Changchun
country: China
facility: Investigational Site Number 1560015
city: Changsha
country: China
facility: Investigational Site Number 1560011
city: Chongqing
country: China
facility: Investigational Site Number 1560030
city: Dalian
country: China
facility: Investigational Site Number 1560019
city: Fuzhou
country: China
facility: Investigational Site Number 1560013
city: Guangzhou
country: China
facility: Investigational Site Number 1560001
city: Guangzhou
country: China
facility: Investigational Site Number 1560027
city: Guilin
country: China
facility: Investigational Site Number 1560037
city: Haikou
country: China
facility: Investigational Site Number 1560031
city: Hengyang
country: China
facility: Investigational Site Number 1560036
city: Hengyang
country: China
facility: Investigational Site Number 1560039
city: Hohhot
country: China
facility: Investigational Site Number 1560023
city: Kunming
country: China
facility: Investigational Site Number 1560033
city: Kunming
country: China
facility: Investigational Site Number 1560034
city: Lanzhou
country: China
facility: Investigational Site Number 1560006
city: Nanchang
country: China
facility: Investigational Site Number 1560004
city: Nanchang
country: China
facility: Investigational Site Number 1560005
city: Nanchang
country: China
facility: Investigational Site Number 1560032
city: Nanjing
country: China
facility: Investigational Site Number 1560017
city: Nanning
country: China
facility: Investigational Site Number 1560029
city: Ningbo
country: China
facility: Investigational Site Number 1560028
city: Shanghai
country: China
facility: Investigational Site Number 1560002
city: Shanghai
country: China
facility: Investigational Site Number 1560007
city: Shenyang
country: China
facility: Investigational Site Number 1560021
city: Shenyang
country: China
facility: Investigational Site Number 1560038
city: Shijiazhuang
country: China
facility: Investigational Site Number 1560025
city: Taiyuan
country: China
facility: Investigational Site Number 1560022
city: Tianjin
country: China
facility: Investigational Site Number 1560012
city: Tianjin
country: China
facility: Investigational Site Number 1560014
city: Wuhan
country: China
facility: Investigational Site Number 1560010
city: Xi'An
country: China
facility: Investigational Site Number 1560008
city: Xiamen
country: China
facility: Investigational Site Number 1560020
city: Xiamen
country: China
facility: Investigational Site Number 1560018
city: Xuzhou
country: China
facility: Investigational Site Number 1560035
city: Yinchuan
country: China
facility: Investigational Site Number 1560024
city: Zhanjiang
country: China
facility: Investigational Site Number 1560016
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: