Clinical trial NCT00742716: Safety Study of CTA018 Injection to Treat Stage 5 Chronic Kidney Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Kidney Disease
Secondary Hyperparathyroidism
Chronic Renal Insufficiency
Chronic Renal Failure
Keywords: Parathyroid Diseases
Renal Insufficiency
Kidney Failure, Chronic
Hyperparathyroidism, Secondary
Vitamin D
Hyperparathyroidism
Renal Insufficiency, Chronic
Kidney Diseases
Kidney Failure
Lead sponsor: OPKO Health, Inc.
Sponsor class: INDUSTRY
First posted: 2008-08-28
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: To assess the single and repeat dose pharmacokinetics (PK) of CTA018 Injection
timeFrame: Day 1 and 12 of each dose level
measure: To investigate the safety of CTA018 Injection
timeFrame: Throughout the study
Secondary outcomes:
measure: To investigate the pharmacodynamic (PD) intact parathyroid hormone (iPTH) response following CTA08 Injection
timeFrame: Throughout the study
measure: To determine the efficacy of CTA018 Injection to reduce serum iPTH
timeFrame: Throughout the study
Other outcomes:
Locations:
city: Pembroke Pines
country: United States
facility: Pines Clinical Research, Inc.
state: Florida
city: Meridian
country: United States
facility: Boise Kidney and Hypertension Institute
state: Idaho
city: Springfield
country: United States
facility: Western New England Renal & Transplant Associates (WNERTA)
state: Massachusetts
city: Chattanooga
country: United States
facility: Southeast Renal Research Institute
state: Tennessee
city: Fort Worth
country: United States
facility: U.S. Renal Care
state: Texas
city: Halifax
country: Canada
facility: Capital District Heatlth Authority: Centre for Clinical Research
state: Nova Scotia
city: London
country: Canada
facility: St. Joseph's Health Care London
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Weston
country: Canada
facility: Humber River Regional Hospital
state: Ontario
city: Greenfield Park
country: Canada
facility: Hôpital Charles-Lemoyne
state: Quebec
city: Montreal
country: Canada
facility: Hôpital du Sacré-Coeur de Montréal
state: Quebec
city: Verdun
country: Canada
facility: Hospital de Verdun
state: Quebec
Study officials:
affiliation: OPKO Renal
name: Joel Melnick, MD
role: STUDY_DIRECTOR
References: