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NCT Number: NCT00742716

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

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.

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Chronic Renal Failure Chronic Renal Insufficiency Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hyperparathyroidism Hyperparathyroidism, Secondary Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Parathyroid Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Secondary Hyperparathyroidism Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Capital District Heatlth Authority: Centre for Clinical Research, Halifax, Nova Scotia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CTA018 Injection

Drug

Comparison of different dosages of drug

Primary outcomes

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

    Time frame: Day 1 and 12 of each dose level

  2. To investigate the safety of CTA018 Injection

    Time frame: Throughout the study

Secondary outcomes

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

    Time frame: Throughout the study

  2. To determine the efficacy of CTA018 Injection to reduce serum iPTH

    Time frame: Throughout the study

Sponsors and collaborators

Lead sponsor

OPKO IP Holdings II, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Aug 28, 2008
Registry last updated
Nov 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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