Safety Study of CTA018 Injection to Treat Stage 5 Chronic Kidney Disease - Full Text View

Purpose

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.

Condition	Intervention	Phase
Chronic Kidney Disease Secondary Hyperparathyroidism Chronic Renal Insufficiency Chronic Renal Failure	Drug: CTA018 Injection	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

MedlinePlus related topics: Chronic Kidney Disease Dialysis Kidney Failure Parathyroid Disorders

U.S. FDA Resources

Further study details as provided by Cytochroma Inc.:

Primary Outcome Measures:

To assess the single and repeat dose pharmacokinetics (PK) of CTA018 Injection [ Time Frame: Day 1 and 12 of each dose level ( a to d) ] [ Designated as safety issue: No ]
To investigate the safety of CTA018 Injection [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To investigate the pharmacodynamic (PD) intact parathyroid hormone (iPTH) response following CTA08 Injection [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
To determine the efficacy of CTA018 Injection to reduce serum iPTH [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]

Enrollment:	40
Study Start Date:	August 2008
Study Completion Date:	June 2010
Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 dose a	Drug: CTA018 Injection Comparison of different dosages of drug administered intravenously, three times per week, for four weeks.
Experimental: 2 dose b	Drug: CTA018 Injection Comparison of different dosages of drug administered intravenously, three times per week, for four weeks.
Experimental: 3 dose c	Drug: CTA018 Injection Comparison of different dosages of drug administered intravenously, three times per week, for four weeks.
Experimental: 4 dose d	Drug: CTA018 Injection Comparison of different dosages of drug administered intravenously, three times per week, for four weeks.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00742716

Locations

United States, Florida
Pines Clinical Research, Inc.
Pembroke Pines, Florida, United States, 33028
United States, Idaho
Boise Kidney and Hypertension Institute
Meridian, Idaho, United States, 83642
United States, Massachusetts
Western New England Renal & Transplant Associates (WNERTA)
Springfield, Massachusetts, United States, 01107-1121
United States, Tennessee
Southeast Renal Research Institute
Chattanooga, Tennessee, United States, 37404
United States, Texas
U.S. Renal Care
Fort Worth, Texas, United States, 76105
Canada, Nova Scotia
Capital District Heatlth Authority: Centre for Clinical Research
Halifax, Nova Scotia, Canada, B3H 1V8
Canada, Ontario
St. Joseph's Health Care London
London, Ontario, Canada, N6A 4V2
St. Michael's Hospital
Toronto, Ontario, Canada, M5N 1W8
Humber River Regional Hospital
Weston, Ontario, Canada, M9N 1N8
Canada, Quebec
Hôpital Charles-Lemoyne
Greenfield Park, Quebec, Canada, J4V 2H1
Hôpital du Sacré-Coeur de Montréal
Montreal, Quebec, Canada, H4J 1C5
Hospital de Verdun
Verdun, Quebec, Canada, H4G 2A3

Sponsors and Collaborators

Cytochroma Inc.

Investigators

Study Director:

Joel Melnick, MD

Cytochroma Inc.

More Information

No publications provided

Responsible Party:	Cytochroma Inc.
ClinicalTrials.gov Identifier:	NCT00742716 History of Changes
Other Study ID Numbers:	CTA018-CL-2002
Study First Received:	August 26, 2008
Last Updated:	July 20, 2012
Health Authority:	Canada: Health Canada United States: Food and Drug Administration

Keywords provided by Cytochroma Inc.:

Parathyroid Diseases
Renal Insufficiency
Kidney Failure, Chronic
Hyperparathyroidism, Secondary
Vitamin D

Hyperparathyroidism
Renal Insufficiency, Chronic
Kidney Diseases
Kidney Failure

Additional relevant MeSH terms:

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

Renal Insufficiency
Parathyroid Diseases
Endocrine System Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013