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

• Status: Not yet recruiting
• Trial end date: 2023-03-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chengdu Suncadia Medicine Co., Ltd.

Criteria

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;