Chronic Kidney Disease, Chronic Renal Failure, Chronic Renal Insufficiency, Secondary Hyperparathyroidism
Conditions
Keywords
Parathyroid Diseases, Renal Insufficiency, Kidney Failure, Chronic, Hyperparathyroidism, Secondary, Vitamin D, Hyperparathyroidism, Renal Insufficiency, Chronic, Kidney Diseases, Kidney Failure
Brief summary
This study will investigate how the levels of a single dose of CTAP101 changes in the body over time (pharmacokinetics, PK) and how CTAP101 affects other mineral and hormonal balances (pharmacodynamics, PD) in patients with Stage 3 or 4 chronic kidney disease (CKD) with vitamin D insufficiency and secondary hyperparathyroidism (SHPT).
Interventions
DRUGCTAP101 Capsules
Single dose oral administration
DRUGCTAP101 Injection
single IV injection
Sponsors
OPKO IP Holdings II, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Body mass index between great than or equal to 18 and less than or equal to 40 kg/m2 * Plasma iPTH value for Stage 3 CKD greater than or equal to 70 pg/mL and lower than or equal to 1000 pg/mL * Plasma iPTH value for Stage 4 CKD greater than or equal to 110 pg/mL and lower than or equal to 1000 pg/mL * Adjusted serum total calcium value greater than 8.4 mg/dL and lower than 10.0 mg/dL * Serum phosphorus value greater than or equal to 2.5 mg/dL and lower than or equal to 5.5 mg/dL * Serum 25-hydroxyvitamin D level greater than 15 ng/mL and lower than 30 ng/mL * Hemoglobin level greater than or equal to 10 g/dL
Exclusion criteria
* Has nephrotic range proteinuria * Has liver disease or significant hepatic dysfunction * Is taking Cytochrome P450 3A4 inhibitors or inducers * Has adult history of kidney stones and dysphagia * Has known history of alcohol/controlled substance abuse or are positive for drug of abuse screen * Currently on dialysis * Current serious illness such as cancer, HIV, cardiovascular event or hepatitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the PK and bioavailability of CTAP101 in Stage 3 and 4 CKD subjects with vitamin D insufficiency and SHPT | from 3 to 0 hours prior to dosing until 42 days post dosing |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of CTAP101 capsules and injection | From signing of ICF (Day -35) through study completion (Day 42 post dosing) |
| To assess the pharmacodynamics of single dose CTAP101 in Stage 3 and Stage 4 CKD subjects with vitamin D insufficiency and SHPT. | From signing of ICF (Day -35) through study completion (Day 42 post dosing) |
Countries
United States
Outcome results
None listed