NCT00742716

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2008

Geographic Reach
2 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 28, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

November 6, 2014

Status Verified

June 1, 2011

Enrollment Period

1.3 years

First QC Date

August 26, 2008

Last Update Submit

October 30, 2014

Conditions

Chronic Kidney DiseaseSecondary HyperparathyroidismChronic Renal InsufficiencyChronic Renal Failure

Keywords

Parathyroid DiseasesRenal InsufficiencyKidney Failure, ChronicHyperparathyroidism, SecondaryVitamin DHyperparathyroidismRenal Insufficiency, ChronicKidney DiseasesKidney Failure

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • 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

Study Arms (4)

CTA018 Injection low dose

EXPERIMENTAL

Low dose IV 3 times a week for 4 weeks

Drug: CTA018 Injection

CTA018 Injection low to mid dose

EXPERIMENTAL

low to mid dose IV 3 times a week for 4 weeks

Drug: CTA018 Injection

CTA018 Injection mid to high dose

EXPERIMENTAL

mid to high dose IV 3 times a week for 4 weeks

Drug: CTA018 Injection

CTA018 Injection high dose

EXPERIMENTAL

high dose IV 3 times a week for 4 weeks

Drug: CTA018 Injection

Interventions

CTA018 InjectionDRUG

Comparison of different dosages of drug

CTA018 Injection high doseCTA018 Injection low doseCTA018 Injection low to mid doseCTA018 Injection mid to high dose

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Pines Clinical Research, Inc.

Pembroke Pines, Florida, 33028, United States

Location

Boise Kidney and Hypertension Institute

Meridian, Idaho, 83642, United States

Location

Western New England Renal & Transplant Associates (WNERTA)

Springfield, Massachusetts, 01107-1121, United States

Location

Southeast Renal Research Institute

Chattanooga, Tennessee, 37404, United States

Location

U.S. Renal Care

Fort Worth, Texas, 76105, United States

Location

Capital District Heatlth Authority: Centre for Clinical Research

Halifax, Nova Scotia, B3H 1V8, Canada

Location

St. Joseph's Health Care London

London, Ontario, N6A 4V2, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5N 1W8, Canada

Location

Humber River Regional Hospital

Weston, Ontario, M9N 1N8, Canada

Location

Hôpital Charles-Lemoyne

Greenfield Park, Quebec, J4V 2H1, Canada

Location

Hôpital du Sacré-Coeur de Montréal

Montreal, Quebec, H4J 1C5, Canada

Location

Hospital de Verdun

Verdun, Quebec, H4G 2A3, Canada

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicHyperparathyroidism, SecondaryKidney Failure, ChronicParathyroid DiseasesRenal InsufficiencyHyperparathyroidismKidney Diseases

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsEndocrine System Diseases

Study Officials

  • Joel Melnick, MD

    OPKO Renal

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2008

First Posted

August 28, 2008

Study Start

October 1, 2008

Primary Completion

February 1, 2010

Study Completion

June 1, 2010

Last Updated

November 6, 2014

Record last verified: 2011-06

Locations

CA(7)US(5)