| Trial ID: | L1666 |
| Source ID: | NCT04994080
|
| Associated Drug: |
Paricalcitol
|
| Title: |
A Study to Assess the Efficacy and Safety of Paricalcitol in the Treatment of Chronic Kidney Disease With Secondary Hyperparathyroidism
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Secondary Hyperparathyroidism
|
| Interventions: |
DRUG: Paricalcitol|DRUG: Placebo
|
| Outcome Measures: |
Primary: Percentage of participants with >30% decrease from basline at least twice in mean iPTH during the efficacy assessment phase., 0-24 weeks | Secondary: The value of iPTH for each visit, 0-24 weeks|The change from baseline of iPTH for each visit, 0-24 weeks|The change percentage of iPTH for each visit;, 0-24 weeks|The proportion of subjects whose iPTH has been reduced by more than 30% from baseline at least 4 consecutive times;, 0-24 weeks|The change value in blood calcium from baseline;, 0-24 weeks|The change value in blood phosphorus from baseline;, 0-24 weeks|The change value in calcium-phosphorus product from baseline;, 0-24 weeks|The change value of 24-hour urine calcium from baseline;, 0-24 weeks|The change value of 24-hour urine phosphorus from baseline;, 0-24 weeks|The change value of 24-hour creatinine clearance rate from baseline;, 0-24 weeks|The change value of eGFR from baseline;, 0-24 weeks|The change value in urine calcium/creatinine ratio from baseline., 0-24 weeks
|
| Sponsor/Collaborators: |
Sponsor: Chengdu Suncadia Medicine Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
84
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2022-02-01
|
| Completion Date: |
2023-03-31
|
| Results First Posted: |
|
| Last Update Posted: |
2022-02-10
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT04994080
|
