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

Secondary Hyperparathyroidism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04994080
• Other study ID #: HR-PLGHC-301
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: February 1, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: July 2021
• Source: Chengdu Suncadia Medicine Co., Ltd.
• Contact: Yin Tong
• Phone: +0518-82342973
• Email: yin.tong[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 84
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Kidney Diseases
• Neoplasm Metastasis
• Renal Insufficiency, Chronic
• Secondary Hyperparathyroidism

Intervention

Drug:
• Paricalcitol
Paricalcitol QD Treatment
• Placebo
Placebo QD or TIW

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chengdu Suncadia Medicine Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants with >30% decrease from basline at least twice in mean iPTH during the efficacy assessment phase.		0-24 weeks
Secondary	The value of iPTH for each visit		0-24 weeks
Secondary	The change from baseline of iPTH for each visit		0-24 weeks
Secondary	The change percentage of iPTH for each visit;		0-24 weeks
Secondary	The proportion of subjects whose iPTH has been reduced by more than 30% from baseline at least 4 consecutive times;		0-24 weeks
Secondary	The change value in blood calcium from baseline;		0-24 weeks
Secondary	The change value in blood phosphorus from baseline;		0-24 weeks
Secondary	The change value in calcium-phosphorus product from baseline;		0-24 weeks
Secondary	The change value of 24-hour urine calcium from baseline;		0-24 weeks
Secondary	The change value of 24-hour urine phosphorus from baseline;		0-24 weeks
Secondary	The change value of 24-hour creatinine clearance rate from baseline;		0-24 weeks
Secondary	The change value of eGFR from baseline;		0-24 weeks
Secondary	The change value in urine calcium/creatinine ratio from baseline.		0-24 weeks