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

OPKO IP Holdings II, Inc.41 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Kidney Disease Secondary Hyperparathyroidism Chronic Renal Insufficiency Chronic Renal Failure

Interventions

CTA018 InjectionDRUG

Comparison of different dosages of drug

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (12)

Pines Clinical Research, Inc.

Pembroke Pines, Florida, United States

Boise Kidney and Hypertension Institute

Meridian, Idaho, United States

Western New England Renal & Transplant Associates (WNERTA)

Springfield, Massachusetts, United States

Outcomes

Primary Outcomes

To assess the single and repeat dose pharmacokinetics (PK) of CTA018 Injection

Time frame: Day 1 and 12 of each dose level

To investigate the safety of CTA018 Injection

Time frame: Throughout the study

Secondary Outcomes

To investigate the pharmacodynamic (PD) intact parathyroid hormone (iPTH) response following CTA08 Injection

Time frame: Throughout the study

To determine the efficacy of CTA018 Injection to reduce serum iPTH

Time frame: Throughout the study

Data from ClinicalTrials.gov

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