Comparison of I.V. CTAP201 and Doxercalciferol (Hectorol) in Subjects With Chronic Kidney Disease (CKD) and Secondary Hyperparathyroidism (SHPT)

OPKO Health

Status and phase: Completed; Phase 1

Conditions: Chronic Kidney Disease; Chronic Renal Failure; Chronic Renal Insufficiency; Secondary Hyperparathyroidism

Treatments: Drug: CTAP201 Injection; Drug: Doxercalciferol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00792857

CTAP201-CL-1007

Details and patient eligibility

About

This study will compare CTAP201 with Doxercalciferol in patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT), undergoing regular hemodialysis, at different dose strengths. This study will also investigate the levels of CTAP201 in the body over time and determine the safety of CTAP201.

Enrollment: 24 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Body mass index between 18 and 40
• On maintenance hemodialysis three times per week
• Visit 1: Serum iPTH value greater than or equal to 200 pg/mL and lower than or equal to 1000 pg/mL
• Visit 1: Serum total calcium value greater than 8.4 mg/dL and lower than 10.0 mg/dL
• Visit 1: 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 or equal to 15 ng/mL
• Visit 2: Serum iPTH value greater than 300 pg/mL
• Visit 2: Serum Ca x P product less than 56 [mg/dl]2
• Willing and able to discontinue vitamin D and/or bone metabolism therapy for at least 2 weeks prior to administration of Study Drug, and length of study

Exclusion criteria

• Taking cytochrome P450 3A inhibitors and/or inducers
• Abnormal liver functions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 4 patient groups

CTAP201 Injection at dose a

Experimental group

Description:

CTAP201 at dose a

Treatment:

Drug: CTAP201 Injection

CTAP201 Injection

Experimental group

Description:

CTAP201 at dose b or dose c

Treatment:

Drug: CTAP201 Injection

Doxercalciferol at dose a

Active Comparator group

Description:

Active at dose a

Treatment:

Drug: Doxercalciferol

Doxercalciferol

Active Comparator group

Description:

Active at dose b or dose c

Treatment:

Drug: Doxercalciferol