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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Secondary Hyperparathyroidism
• Intervention / Treatment: Drug: Paricalcitol; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 84
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Yin Tong; Phone Number: +0518-82342973; Email: yin.tong@hengrui.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Treatment group C	Drug: Placebo; Placebo QD or TIW
Experimental: Treatment group A/B	Drug: Paricalcitol; Paricalcitol QD Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Chengdu Suncadia Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2022
• Primary Completion (Anticipated): March 31, 2023
• Study Completion (Anticipated): March 31, 2023

Study Registration Dates

• First Submitted: July 21, 2021
• First Submitted That Met QC Criteria: July 29, 2021
• First Posted (Actual): August 6, 2021

Study Record Updates

• Last Update Posted (Actual): February 10, 2022
• Last Update Submitted That Met QC Criteria: January 27, 2022
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Urologic Diseases; Endocrine System Diseases; Renal Insufficiency; Parathyroid Diseases; Neoplastic Processes; Kidney Diseases; Renal Insufficiency, Chronic; Hyperparathyroidism; Neoplasm Metastasis; Hyperparathyroidism, Secondary
• Other Study ID Numbers: HR-PLGHC-301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No