Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03001011 | Evaluation of Renvela in Patients With Chronic Kidney Disease Not On Dialysis And Hyperphosphatemia In China | PHASE3 | COMPLETED | 202 | — | — | Jun 7, 2017 | Aug 16, 2019 | Mar 25, 2022 | 38 | China |
| NCT01574326 | An Efficacy and Safety Study of Sevelamer Carbonate in Hyperphosphatemic Pediatric Participants With Chronic Kidney Disease | PHASE2 | COMPLETED | 101 | — | — | May 1, 2012 | Jun 1, 2015 | Jul 25, 2016 | 32 | United States, France +3 |
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.
Full analysis set for fixed dose period (FAS-FDP) participants were analyzed according to their randomized treatment. The change in serum phosphorus (mg/dL) from baseline to week 2 was calculated.
A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect. AEs from the time of signing the informed consent through the end of the study for all participants. SAEs occurring during the 15 days following study completion or early termination were also to be collected.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | 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). |
| Renvela | EXPERIMENTAL | 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). |
| FDP-Placebo for Sevelamer Carbonate, DTP-Sevelamer Carbonate | PLACEBO_COMPARATOR | Participants received placebo for 2 weeks during the fixed dose period (FDP). Participants received sevelamer carbonate for 26 weeks in dose titration period (DTP). |
| FDP-Sevelamer Carbonate, DTP-Sevelamer Carbonate | EXPERIMENTAL | Participants received sevelamer carbonate for 2 weeks during the FDP of the study. Participants received sevelamer carbonate for an additional 26 weeks in DTP. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Pharmaceutical form: tablet Route of administration: oral |
| Sevelamer Carbonate (GZ419831) | DRUG | Pharmaceutical form: tablet Route of administration: oral |
| Sevelamer carbonate | DRUG | 0.8 g sachets of powder for oral suspension or 800 mg tablets |
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 ...