A Study to Assess the Efficacy and Safety of Paricalcitol in the Treatment of Chronic Kidney Disease With Secondary Hyperparathyroidism

Phase 3

• Conditions: Secondary Hyperparathyroidism
• Interventions: Drug: Paricalcitol; Drug: Placebo

• Registration Number: NCT04994080
• Lead Sponsor: Chengdu Suncadia Medicine Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-07
• Study First Submitted: 2021-07-21
• Study First Submitted QC: 2021-07-29
• Study First Posted: 2021-08-06
• Last Update Submitted: 2022-01-27
• Study Start: 2022-02-01
• Last Update Posted: 2022-02-10
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 84

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group A/B	Paricalcitol	-
Treatment group C	Placebo	-

Primary Outcome Measures

Name	Time	Method
Percentage of participants with >30% decrease from basline at least twice in mean iPTH during the efficacy assessment phase.	0-24 weeks

Secondary Outcome Measures

Name	Time	Method
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