Trial · NCT03001011

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

NCT03001011, Phase 3, Completed, Sanofi; results first posted 2020-07-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Evaluation of Renvela in Patients With Chronic Kidney Disease Not On Dialysis And Hyperphosphatemia In China. Trials, record NCT03001011. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03001011

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Evaluation of Renvela in Patients With Chronic Kidney Disease Not On Dialysis And Hyperphosphatemia In China
NCT number: NCT03001011
Status: Completed
Phases: Phase 3
Enrollment: 202 participants, actual
Lead sponsor: Sanofi
Conditions: Hyperphosphatemia
Interventions: Placebo, Sevelamer Carbonate (GZ419831)
First posted: 2016-12-22
Last updated: 2022-03-25
Results first posted: 2020-07-28

Source ClinicalTrials.gov

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Serum Phosphorus at Week 8	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.
Secondary	Change From Baseline in Total Cholesterol at Week 8	Baseline, Week 8	Missing Week 8 data were imputed by LOCF method.
Secondary	Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 8	Baseline, Week 8	Missing Week 8 data were imputed by LOCF method.
Secondary	Change From Baseline in Calcium-Phosphorus Product at Week 8	Baseline, Week 8	Missing Week 8 data were imputed by LOCF method.
Secondary	Change From Baseline in Intact Parathyroid Hormone (Ipth) Level at Week 8	Baseline, Week 8	Missing Week 8 data were imputed by LOCF method.
Secondary	Percentage of Participants Reaching the Target Serum Phosphorus Level (4.6 mg/dL [1.49 mmol/L]) at Week 8	Week 8	Missing Week 8 data were imputed by LOCF method.
Secondary	Change From Baseline in Serum Phosphorus Level at Week 4	Baseline, Week 4	Missing Week 4 data were imputed by LOCF method.
Secondary	Number of Participants With Treatment Emergent Adverse Event	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.
Secondary	Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters	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: * Hemoglobin: \<=115 g/L (Male\[M\]) or \<=95 g/L (Female \[F\]); \>=185 g/L (M) or \>=165 g/L (F); Decrease from baseline (DFB) \>=20 g/L * Hematocrit: \<=0.37 v/v (M) or \<=0.32 v/v (F); \>=0.55 v/v (M) or \>=0.5 v/v (F) * Red blood cells (RBC): \>=6 Tera/L * Platelets: \<100 Giga/L; \>=700 Giga/L * White blood cells (WBC): \<3.0 Giga/L (Non-Black \[NB\]) or \<2.0 Giga/L (Black \[B\]); \>=16.0 Giga/L * Neutrophils: \<1.5 Giga/L (NB) or \<1.0 Giga/L (B); \<1.0 Giga/L * Lymphocytes: \>4.0 Giga/L * Monocytes: \>0.7 Giga/L * Basophils: \>0.1 Giga/L * Eosinophils: \>0.5 Giga/L or \>upper limit of normal (ULN) (if ULN \>=0.5 Giga/L)
Secondary	Number of Participants With Clinically Significant Laboratory Abnormalities: Metabolic Parameters	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: * Glucose: \<=3.9 mmol/L and \< lower limits of normal (LLN); \>=11.1 mmol/L (unfasted \[unfas\]) or \>=7 mmol/L (fasted \[fas\]) * Triglycerides: \>=4.6 mmol/L * Albumin: \<= 25 g/L.

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes14

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Serum Phosphorus at Week 8	Baseline, Week 8	Modified intention to treat (mITT) population: all participants who were randomized, received at least 1 dose of IMP \& had both baseline assessment \& at least 1 post-baseline assessment of phosphorus measure. Here, number analyzed = participants with available data at specified time points.	mmol/L	MEDIAN
SECONDARY	Change From Baseline in Total Cholesterol at Week 8	Baseline, Week 8	Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.	mmol/L	MEDIAN
SECONDARY	Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 8	Baseline, Week 8	Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.	mmol/L	MEDIAN
SECONDARY	Change From Baseline in Calcium-Phosphorus Product at Week 8	Baseline, Week 8	Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.	mmol^2/L^2	MEDIAN
SECONDARY	Change From Baseline in Intact Parathyroid Hormone (Ipth) Level at Week 8	Baseline, Week 8	Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.	nanogram per liter (ng/L)	MEDIAN
SECONDARY	Percentage of Participants Reaching the Target Serum Phosphorus Level (4.6 mg/dL [1.49 mmol/L]) at Week 8	Week 8	Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.	percentage of participants	NUMBER
SECONDARY	Change From Baseline in Serum Phosphorus Level at Week 4	Baseline, Week 4	Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.	mmol/L	MEDIAN
SECONDARY	Number of Participants With Treatment Emergent Adverse Event	From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59	Analysis was performed on safety population that consisted of all randomized participants who received at least one dose of IMP.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters	From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59	Analysis was performed on safety population. Here, number analyzed = participants with available data for the specified categories.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Clinically Significant Laboratory Abnormalities: Metabolic Parameters	From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59	Analysis was performed on safety population. Here, number analyzed = participants with available data for specified categories.	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 14Source ClinicalTrials.gov

See all 14 outcomes

Results by group124

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in Serum Phosphorus at Week 8	Placebo	Baseline	2.090	Full Range 1.870 to 2.270	mmol/L
Change From Baseline in Serum Phosphorus at Week 8	Renvela	Baseline	2.095	Full Range 1.870 to 2.400	mmol/L
Change From Baseline in Serum Phosphorus at Week 8	Placebo	Change at Week 8	0.010	Full Range -0.200 to 0.250	mmol/L
Change From Baseline in Serum Phosphorus at Week 8	Renvela	Change at Week 8	-0.200	Full Range -0.490 to 0.020	mmol/L
Change From Baseline in Total Cholesterol at Week 8	Placebo		-0.115	Full Range -1.82 to 1.54	mmol/L
Change From Baseline in Total Cholesterol at Week 8	Renvela		-0.830	Full Range -4.45 to 0.74	mmol/L
Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 8	Placebo		-0.030	Full Range -1.61 to 1.30	mmol/L
Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 8	Renvela		-0.830	Full Range -3.31 to 0.51	mmol/L
Change From Baseline in Calcium-Phosphorus Product at Week 8	Placebo		0.0200	Full Range -2.648 to 2.936	mmol^2/L^2
Change From Baseline in Calcium-Phosphorus Product at Week 8	Renvela		-0.4960	Full Range -2.592 to 2.696	mmol^2/L^2

1 to 10 of 124Source ClinicalTrials.gov

See all 124 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	101
Overall Study	STARTED	Renvela	101
Overall Study	COMPLETED	Placebo	74
Overall Study	COMPLETED	Renvela	80
Overall Study	NOT COMPLETED	Placebo	27
Overall Study	NOT COMPLETED	Renvela	21

Source ClinicalTrials.gov

Adverse events80

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Abdominal Distension	Gastrointestinal disorders	Placebo	5	101	5
other	Abdominal Distension	Gastrointestinal disorders	Renvela	6	101	7
other	Constipation	Gastrointestinal disorders	Placebo	5	101	5
other	Constipation	Gastrointestinal disorders	Renvela	7	101	8
other	Diarrhoea	Gastrointestinal disorders	Placebo	8	101	10
other	Diarrhoea	Gastrointestinal disorders	Renvela	5	101	5
other	Nausea	Gastrointestinal disorders	Placebo	15	101	15
other	Nausea	Gastrointestinal disorders	Renvela	10	101	11
other	Vomiting	Gastrointestinal disorders	Placebo	13	101	17
other	Vomiting	Gastrointestinal disorders	Renvela	12	101	20

1 to 10 of 80Source ClinicalTrials.gov

See all 80 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	101
Total, all-cause mortality	Renvela	0	101
Total, other adverse events	Placebo	52	101
Total, other adverse events	Renvela	60	101
Total, serious adverse events	Placebo	31	101
Total, serious adverse events	Renvela	26	101

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
40576086	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Renvela vs Placebo: deaths from any cause	Trial comparisons
Renvela vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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