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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00742716

Enrollment

Registered

2008-08-28

Start date

2008-10-31

Completion date

2010-06-30

Last updated

2014-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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 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.

Interventions

DRUGCTA018 Injection

Comparison of different dosages of drug

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026