Clinical trial NCT04994080: A Study to Assess the Efficacy and Safety of Paricalcitol in the Treatment of Chronic Kidney Disease With Secondary Hyperparathyroidism
Official title: A Multi-center, Randomized, Double-blind, Parallel Grouping, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Paricalcitol Soft Capsules in the Treatment of Secondary Hyperparathyroidism in Subjects With Stage 3 and Stage 4 Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Secondary Hyperparathyroidism
Lead sponsor: Chengdu Suncadia Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-08-06
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A multi-center, randomized, double-blind, parallel grouping, placebo-controlled phase 3 study
Primary purpose: TREATMENT

Brief summary: The study is being conducted to evaluate the efficacy, and safety of Paricalcitol for secondary hyperparathyroidism with stage 3 and stage 4 chronic kidney disease in adults.


Eligibility criteria: Inclusion Criteria:

1. Under care of physician at least 2 months for CKD
2. Not on active Vitamin D and Calcimimetic therapy for at least 4 weeks prior
3. If taking phosphate binders, on a stable regimen at least 4 weeks prior
4. For entry into Pretreatment Phase:

   iPTH at least 120 pg/mL GFR of 15-60 mL/min and no dialysis expected for at least 6 months
5. For entry into Treatment Phase:

Average of 2 consecutive iPTH values of at least 150 pg/mL, taken at least 1 day apart (all values not less than 120 pg/mL) 2 consecutive corrected serum calcium levels between 8.0-10.0 mg/dL 2 consecutive serum phosphorus levels of not more than 5.2 mg/mL

Exclusion Criteria:

1. Subjects who had Primary hyperparathyroidism;
2. Subjects with a history of acute renal failure;
3. Subjects with chronic gastrointestinal disease or severe liver disease with clinical symptoms;
4. Subjects with a history of unstable angina, grade III or IV congestive heart failure, and/or clinically meaningful arrhythmia;
5. Subjects with serum albumin \< 30g/L, serum hemaoglobin \< 85g/L, or serum transaminase higher than 2.5 times the upper limit of nomal;
6. Subjects with a history of malignancy;
7. Subjects who plan to undergo surgery during the study period;
8. Subjects with a history active granulomatous diseases;
9. Subject with a history of alcohol abuse and drug abuse;
10. Human immunodeficiency virus antibody (HIV-Ab), hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab) or Treponema pallidum antibody (TP-Ab) are positive;
11. Subjects who are allergic to the test drug and its ingredients or excipients;
12. Subjects who combined with systemic or systemic diseases that are not suitable for clinical trials;
13. Subjects who have participated in clinical trials of other drugs or devices;

Primary outcomes:
measure: Percentage of participants with >30% decrease from basline at least twice in mean iPTH during the efficacy assessment phase.
timeFrame: 0-24 weeks
Secondary outcomes:
measure: The value of iPTH for each visit
timeFrame: 0-24 weeks
measure: The change from baseline of iPTH for each visit
timeFrame: 0-24 weeks
measure: The change percentage of iPTH for each visit;
timeFrame: 0-24 weeks
measure: The proportion of subjects whose iPTH has been reduced by more than 30% from baseline at least 4 consecutive times;
timeFrame: 0-24 weeks
measure: The change value in blood calcium from baseline;
timeFrame: 0-24 weeks
measure: The change value in blood phosphorus from baseline;
timeFrame: 0-24 weeks
measure: The change value in calcium-phosphorus product from baseline;
timeFrame: 0-24 weeks
measure: The change value of 24-hour urine calcium from baseline;
timeFrame: 0-24 weeks
measure: The change value of 24-hour urine phosphorus from baseline;
timeFrame: 0-24 weeks
measure: The change value of 24-hour creatinine clearance rate from baseline;
timeFrame: 0-24 weeks
measure: The change value of eGFR from baseline;
timeFrame: 0-24 weeks
measure: The change value in urine calcium/creatinine ratio from baseline.
timeFrame: 0-24 weeks
Other outcomes:
Locations:
Study officials:
References: