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

Chengdu Suncadia Medicine

Status and phase: Unknown; Phase 3

Conditions: Secondary Hyperparathyroidism

Treatments: Drug: Paricalcitol; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04994080

HR-PLGHC-301

Details and patient eligibility

About

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.

Enrollment: 84 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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84 participants in 2 patient groups, including a placebo group

Treatment group A/B

Experimental group

Treatment:

Drug: Paricalcitol

Treatment group C

Placebo Comparator group

Treatment:

Drug: Placebo