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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2023-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Secondary Hyperparathyroidism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment group A/B

Group Type EXPERIMENTAL

Paricalcitol

Intervention Type DRUG

Paricalcitol QD Treatment

Treatment group C

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo QD or TIW

Interventions

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Paricalcitol

Paricalcitol QD Treatment

Intervention Type DRUG

Placebo

Placebo QD or TIW

Intervention Type DRUG

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No