Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency
Chronic Kidney Disease, Hyperparathyroidism, Secondary, Vitamin D Deficiency
About this trial
This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Parathyroid Diseases, Renal Insufficiency, Kidney Failure, Chronic, Hyperparathyroidism, Secondary, Vitamin D, Hyperparathyroidism, Kidney Diseases, Kidney Failure, Renal Insufficiency, Chronic
Eligibility Criteria
Inclusion Criteria:
- Urinary albumin excretion ≤ 3000 mcg/mg of creatinine
- Stage 3 or 4 CKD
- Plasma iPTH: ≥ 85 pg/mL and < 500 pg/mL
- Serum Ca: ≥ 8.4 mg/dL and < 9.8 mg/dL
- Serum P: ≥ 2.0 mg/dL and < 5.0 mg/dL
- Serum 25-hydroxyvitamin D: ≥ 10 ng/mL and < 30 ng/mL.
- Stable dose of Vitamin D therapy ≤ 1600 IU/day and receiving same dose for at least 2 months
Exclusion Criteria:
- History of kidney transplant or parathyroidectomy
- Spot urine calcium:creatinine ratio > 0.2 (>200 mg/g Cr)
- Current serious illness, such as malignancy, HIV, liver disease, cardiovascular event or hepatitis
- Currently on dialysis
- Use of pharmacological dose of ergocalciferol or cholecalciferol (≥ 50,000 IU mcg per month) during the study
Sites / Locations
- OPKO Renal
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
CTAP101 30 μg capsules
Sugar pill to CTAP101 30 μg capsule
1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.
1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.