Study of Safety and Efficacy of Doxercalciferol in Patients With Chronic Kidney Disease, Stage 3 or 4, and Secondary Hyperparathyroidism

Genzyme

Status and phase

Completed

Phase 4

Conditions

Renal Failure

Chronic Renal Insufficiency

Secondary Hyperparathyroidism

Treatments

Drug: Hectorol (doxercalciferol capsules), 0.5mcg

Study type

Interventional

Funder types

Industry

Identifiers

NCT00123461

BCI-CH-151

Details and patient eligibility

About

The purpose of this study is to demonstrate the safety and effectiveness of Hectorol® (doxercalciferol) capsules in treating patients with Stage 3 or Stage 4 chronic kidney disease (CKD) with secondary hyperparathyroidism who have vitamin D levels in the normal range. Previous studies with doxercalciferol were conducted in patients who had low levels of vitamin D.

Enrollment

70 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Plasma iPTH value above 110 pg/mL for CKD Stage 3 subjects or above 150 pg/mL for CKD Stage 4
Serum 25-hydroxyvitamin D level greater than or equal to 30 ng/mL
CKD Stage 3 evidenced by a glomerular filtration rate (GFR) from the abbreviated MDRD equation between 30-59 mL/min or CKD Stage 4 evidenced by a glomerular filtration rate (GFR) from the abbreviated MDRD equation between 15-29 mL/min

Exclusion criteria