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

NCT04994080 | Unknown Phase 3

• 1 other identifier: HR-PLGHC-301
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Secondary Hyperparathyroidism

Outcome Measures

Primary Outcomes (1)

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

  0-24 weeks

Secondary Outcomes (12)

• 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

Study Arms (2)

Treatment group A/B

EXPERIMENTAL

Drug: Paricalcitol

Treatment group C

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Paricalcitol DRUG

Paricalcitol QD Treatment

Treatment group A/B

Placebo DRUG

Placebo QD or TIW

Treatment group C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;
• Subjects who are allergic to the test drug and its ingredients or excipients;
• Subjects who combined with systemic or systemic diseases that are not suitable for clinical trials;
• Subjects who have participated in clinical trials of other drugs or devices;

Sponsors & Collaborators

• Chengdu Suncadia Medicine Co., Ltd.: lead

MeSH Terms

Conditions

Hyperparathyroidism, Secondary

Interventions

paricalcitol

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Central Study Contacts

Yin Tong

CONTACT

+0518-82342973; yin.tong@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A multi-center, randomized, double-blind, parallel grouping, placebo-controlled phase 3 study

Study Record Dates

• First Submitted: July 21, 2021
• First Posted: August 6, 2021
• Study Start: February 1, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: February 10, 2022

Record last verified: 2021-07