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

Chengdu Suncadia Medicine Co., Ltd.0 sites84 target enrollmentFebruary 1, 2022

ConditionsSecondary Hyperparathyroidism

InterventionsParicalcitol Placebo

DrugsParicalcitol Placebo

Overview

Phase: Phase 3
Intervention: Paricalcitol
Conditions: Secondary Hyperparathyroidism
Sponsor: Chengdu Suncadia Medicine Co., Ltd.
Enrollment: 84
Primary Endpoint: Percentage of participants with >30% decrease from basline at least twice in mean iPTH during the efficacy assessment phase.
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 1, 2022

End Date

March 31, 2023

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Chengdu Suncadia Medicine Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Under care of physician at least 2 months for CKD
•Not on active Vitamin D and Calcimimetic therapy for at least 4 weeks prior
•If taking phosphate binders, on a stable regimen at least 4 weeks prior
•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
•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

•Subjects who had Primary hyperparathyroidism;
•Subjects with a history of acute renal failure;
•Subjects with chronic gastrointestinal disease or severe liver disease with clinical symptoms;
•Subjects with a history of unstable angina, grade III or IV congestive heart failure, and/or clinically meaningful arrhythmia;
•Subjects with serum albumin \< 30g/L, serum hemaoglobin \< 85g/L, or serum transaminase higher than 2.5 times the upper limit of nomal;
•Subjects with a history of malignancy;
•Subjects who plan to undergo surgery during the study period;
•Subjects with a history active granulomatous diseases;
•Subject with a history of alcohol abuse and drug abuse;
•Human immunodeficiency virus antibody (HIV-Ab), hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab) or Treponema pallidum antibody (TP-Ab) are positive;

Arms & Interventions

Treatment group A/B

Intervention: Paricalcitol

Treatment group C

Intervention: Placebo

Outcomes

Primary Outcomes

Percentage of participants with >30% decrease from basline at least twice in mean iPTH during the efficacy assessment phase.

Time Frame: 0-24 weeks

Secondary Outcomes

The change value in blood 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)
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 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)