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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A/B | Experimental |
| |
| Treatment group C | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paricalcitol | Drug | Paricalcitol QD Treatment |
| |
| Placebo |
| 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 |
| 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; |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yin Tong | Contact | +0518-82342973 | yin.tong@hengrui.com |
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| ID | Term |
|---|---|
| D006962 | Hyperparathyroidism, Secondary |
| ID | Term |
|---|---|
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C084656 | paricalcitol |
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A multi-center, randomized, double-blind, parallel grouping, placebo-controlled phase 3 study
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| Drug |
Placebo QD or TIW |
|
| 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 |