Logo 1 Logo 2

Clinical Trial Details

Trial ID: L0792
Source ID: NCT03644264
Associated Drug: Pa21
Title: PA21 Safety and Efficacy in Adult Chinese Subjects
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Chronic Kidney Disease Requiring Chronic Dialysis|Hyperphosphatemia
Interventions: DRUG: PA21|DRUG: sevelamer carbonate
Outcome Measures: Primary: Serum phosphorus (mmol/l ), Change from baseline in serum phosphorus levels at Week 12: comparison between PA21 group and sevelamer carbonate group., baseline and 12 weeks | Secondary: Serum phosphorus (mmol/l ), Serum phosphorus levels at each time point and change from baseline (BL), baseline, weeks 1, 2, 4, 6, 8, 12|Serum phosphorus (mmol/l), % of subjects with serum phosphorus within 1.13 to 1.78 mmol/l, baseline, weeks 1, 2, 4, 6, 8, 12|Adverse events (AEs), Frequency of AEs determined by seriousness, severity and relatedness to study drugs, baseline, weeks 1, 2, 4, 6, 8, 12|Diarrhoea., Frequency of AE of special interest - diarrhoea., baseline, weeks 1, 2, 4, 6, 8, 12|Withdrawals due to AEs, Percentage of withdrawals due to AEs, baseline, weeks 1, 2, 4, 6, 8, 12|Serum calcium (mmol/l), Serum total calcium levels at each time point and change from baseline, baseline, weeks 1, 2, 4, 6, 8, 12|Hypercalcemia (mmol/l), Percentage of subjects that develop at least 1 episode of sustained hypercalcaemia (\>10.0 mg/dl; \>2.5 mmol/l) during study participation, baseline, weeks 1, 2, 4, 6, 8, 12|Serum iPTH (pg/ml), Serum iPTH levels at specified time points and change from baseline, baseline, weeks 8, 12|Serum iron (mcg/dl), Serum iPTH levels at specified time points and change from baseline, baseline, weeks 4, 8, 12|Serum ferritin (mcg/l), Serum ferritin levels at specified time points and change from baseline, baseline, weeks 4, 8, 12|Serum transferrin (mcg/dl), Serum transferrin measured at specified timepoints, baseline, weeks 4, 8, 12|Transferrin saturation (TSAT) (%), TSAT measured at specified timepoints, baseline, weeks 4, 8, 12
Sponsor/Collaborators: Sponsor: Vifor Fresenius Medical Care Renal Pharma
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 286
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2018-08-31
Completion Date: 2020-08-21
Results First Posted:
Last Update Posted: 2021-06-02
Locations: Southern Medical University Nanfang Hospital, Guangzhou, Guangdong, China
URL: https://clinicaltrials.gov/show/NCT03644264