Safety Study of CTA018 Injection to Treat Stage 5 Chronic Kidney Disease

OPKO Health

Status and phase: Completed; Phase 2

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

Treatments: Drug: CTA018 Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT00742716

CTA018-CL-2002

Details and patient eligibility

About

This study will investigate the levels of CTA018 in the body over time (pharmacokinetics, PK) in patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT), undergoing regular hemodialysis. This study will also investigate the safety and effects of different strengths of CTA018, on parathyroid hormone (PTH) levels.

Enrollment: 41 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Body mass index between 18 and 35
• On maintenance hemodialysis three times per week
• Serum iPTH value greater than or equal to 300 pg/mL and lower than or equal to 1000 pg/mL
• Adjusted or total serum calcium value greater than or equal to 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 or equal to 15 ng/mL
• Willing and able to discontinue vitamin D and/or bone metabolism therapy for at least 2 weeks prior to administration of Study Drug, and the length of study

Exclusion criteria

• On bisphosphonates for at least three months prior to first dose of Study Drug
• Currently taking cytochrome P450 3A inhibitors and/or inducers
• Abnormal liver functions

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 4 patient groups

CTA018 Injection low dose

Experimental group

Description:

Low dose IV 3 times a week for 4 weeks

Treatment:

Drug: CTA018 Injection

CTA018 Injection low to mid dose

Experimental group

Description:

low to mid dose IV 3 times a week for 4 weeks

Treatment:

Drug: CTA018 Injection

CTA018 Injection mid to high dose

Experimental group

Description:

mid to high dose IV 3 times a week for 4 weeks

Treatment:

Drug: CTA018 Injection

CTA018 Injection high dose

Experimental group

Description:

high dose IV 3 times a week for 4 weeks

Treatment:

Drug: CTA018 Injection