Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Zemplar · 2 trials · 3 indications
UACR is defined as the ratio: milligram of albumin per gram of creatinine. Baseline UACR was determined as the mean of the 3 UACR measurements from FMV urine collections obtained within 1 week prior to the day of the first dose of study drug. The last on-treatment measurement was the mean of the 3 UACR measurements obtained from FMV urine collections obtained within 1 week of the final week of treatment. The UACR data were log transformed prior to analysis.
| Arm | Type | Description |
|---|---|---|
| Paricalcitol 1 mcg | ACTIVE_COMPARATOR | One paricalcitol 1 mcg capsule and one matching placebo capsule per dose |
| Paricalcitol 2 mcg | ACTIVE_COMPARATOR | Two paricalcitol 1 mcg capsules per dose |
| Placebo | PLACEBO_COMPARATOR | Two placebo capsules per dose |
| Name | Type | Description |
|---|---|---|
| Zemplar Capsule | DRUG | - |
| Zemplar (paricalcitol ) capsules | DRUG | Group 2 - paricalcitol 1 mcg capsules once daily (one paricalcitol 1 mcg capsule once daily and one matching placebo capsule once daily) |
| Zemplar (paricalcitol) capsules | DRUG | Group 3 - paricalcitol 2 mcg capsules once daily (two paricalcitol 1 mcg capsules once daily) |
| Placebo | DRUG | Group 1 - Placebo once daily (two placebo capsules once daily) |
Inclusion Criteria * Subject was at least 18 years of age, diagnosed with CKD Stage 5 and undergoing HD or PD. * If female, subject was either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hys...
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Zemplar is used for kidney disease and diabetic nephropathy. It is being studied in chronic kidney disease patients on hemodialysis or peritoneal dialysis to reduce serum intact parathyroid hormone levels, and in type 2 diabetic nephropathy patients to reduce albuminuria while they are treated with renin-angiotensin system inhibitors.
Zemplar targets the parathyroid hormone pathway. It is a small molecule developed by Abbott Laboratories for nephrology indications, specifically to reduce serum intact parathyroid hormone levels in chronic kidney disease and to reduce albuminuria in diabetic nephropathy.
Zemplar is developed by Abbott Laboratories, traded on the stock exchange under the ticker ABT. The company is conducting clinical trials for the drug in kidney disease and diabetic nephropathy indications.
Zemplar is in Phase 2 clinical development. One Phase 2 trial has been completed, and the drug remains investigational. It is not approved by the FDA, and it is still being studied for its safety and efficacy in kidney disease and diabetic nephropathy.
Zemplar has one completed Phase 2 trial, NCT00421733, which studied the effect of paricalcitol capsules on reducing albuminuria in patients with type 2 diabetic nephropathy. A separate Phase 3 trial, NCT00091975, studied the drug in chronic kidney disease stage 5 patients on dialysis.
Yes, Zemplar is the same as paricalcitol. The clinical trials for Zemplar use paricalcitol capsules as the investigational treatment, and the drug is a small molecule developed by Abbott Laboratories for kidney disease and diabetic nephropathy.