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

Study Overview
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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.

Official Title
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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

Conditions
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Secondary Hyperparathyroidism

Intervention / Treatment
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* Drug: Paricalcitol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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; 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;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A multi-center, randomized, double-blind, parallel grouping, placebo-controlled phase 3 study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group A/B<br> | Drug: Paricalcitol<br>* Paricalcitol QD Treatment<br>|
| Placebo Comparator: Treatment group C<br> | Drug: Placebo<br>* Placebo QD or TIW<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 |