Secondary Hyperparathyroidism
Conditions
Brief 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.
Interventions
DRUGParicalcitol
Paricalcitol QD Treatment
DRUGPlacebo
Placebo QD or TIW
Sponsors
Chengdu Suncadia Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
A multi-center, randomized, double-blind, parallel grouping, placebo-controlled phase 3 study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 value of iPTH for each visit | 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 |
| The change value in calcium-phosphorus product from baseline; | 0-24 weeks |
Contacts
Primary ContactYin Tong
Outcome results
None listed