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

Study Overview
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Brief Summary
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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.

Official Title
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An Open Label, Four Week, Dose Escalating Pharmacokinetic, Pharmacodynamic, Efficacy and Safety Study of CTA018 Injection in Subjects With Stage 5 Chronic Kidney Disease With Secondary Hyperparathyroidism on Hemodialysis

Conditions
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Chronic Kidney Disease, Secondary Hyperparathyroidism, Chronic Renal Insufficiency, Chronic Renal Failure

Intervention / Treatment
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* Drug: CTA018 Injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CTA018 Injection low dose<br>Low dose IV 3 times a week for 4 weeks | Drug: CTA018 Injection<br>* Comparison of different dosages of drug<br>|
| Experimental: CTA018 Injection low to mid dose<br>low to mid dose IV 3 times a week for 4 weeks | Drug: CTA018 Injection<br>* Comparison of different dosages of drug<br>|
| Experimental: CTA018 Injection mid to high dose<br>mid to high dose IV 3 times a week for 4 weeks | Drug: CTA018 Injection<br>* Comparison of different dosages of drug<br>|
| Experimental: CTA018 Injection high dose<br>high dose IV 3 times a week for 4 weeks | Drug: CTA018 Injection<br>* Comparison of different dosages of drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the single and repeat dose pharmacokinetics (PK) of CTA018 Injection |  | Day 1 and 12 of each dose level | 
| To investigate the safety of CTA018 Injection |  | Throughout the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the pharmacodynamic (PD) intact parathyroid hormone (iPTH) response following CTA08 Injection |  | Throughout the study | 
| To determine the efficacy of CTA018 Injection to reduce serum iPTH |  | Throughout the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parathyroid Diseases, Renal Insufficiency, Kidney Failure, Chronic, Hyperparathyroidism, Secondary, Vitamin D, Hyperparathyroidism, Renal Insufficiency, Chronic, Kidney Diseases, Kidney Failure