DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Phase II Pharmacokinetics, Efficacy, and Safety of Belatacept in Pediatric Renal Transplant Recipients

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Kidney Transplant

Intervention: Belatacept (Drug); Tacrolimus (Drug); CsA (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

Overall contact:
Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:, Email: Clinical.Trials@bms.com

Summary

The purpose of this study is to assess the pharmacokinetics (PK) efficacy and safety of Belatacept in stable pediatric renal transplant recipients.

Clinical Details

Official title: A Phase 2 Multi-Center, Randomized Conversion Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Belatacept Administered to Pediatric Subjects With a Stable Renal Transplant

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Time of maximum observed serum concentration (Tmax)

Maximum observed serum concentration (Cmax)

Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]

Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)]

Half-life (T-HALF)

Total body clearance (CLT)

Volume of distribution at steady-state (Vss)

Steady state trough concentration (Cmin)

Secondary outcome:

Safety will be measured by proportion of subjects reporting Adverse Event (AE), Serious AE, and AE leading to early discontinuation

Antibody titers against Belatacept

CD86 receptor occupancy in Blood samples

Efficacy as measured by estimated glomerular filtration rate (eGFR) [calculated by updated Schwartz formula]

Efficacy as measured by change in eGFR

Efficacy as measured by incidence and severity of AR

Efficacy as measured by incidence of death and graft loss

Eligibility

Minimum age: 6 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

For more information regarding BMS clinical trial participation, please visit www. BMSStudyConnect. com Inclusion Criteria:

- 6-17 years old

- Recipients of a renal allograft from a living donor or a deceased donor at least 6

months prior to enrollment

- Subject must be receiving a calcineurin inhibitor (CNI)-based [cyclosporine (CsA)

[any formulation] or Tacrolimus (TAC)] immunosuppressive regimen

- Subject must be receiving adjunctive background maintenance immunosuppression with

mycophenolate mofetil (MMF) or enteric-coated mycophenolate sodium (EC-MPS)/mycophenolic acid (MPA)

- Subjects must be receiving a stable dose of corticosteroids

- Subject must have stable estimated glomerular filtration rate (GFR) ≥45 mL/min/1. 73m2

(updated Schwartz formula) Exclusion Criteria:

- Epstein-Barr virus (EBV) serostatus negative or unknown at time of transplant and

screening

- History of any treated or biopsy proven acute rejection (BPAR) within 3 months prior

to randomization

- Subjects who have experienced more than 1 episode of acute rejection (AR) of the

current allograft or any antibody-mediated AR

- Significant proteinuria

- Active infection

Locations and Contacts

Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:, Email: Clinical.Trials@bms.com

University Of Alabama At Birmingham, Birmingham, Alabama 35233, United States; Recruiting
Daniel Feig, Site 0004, Phone: 205-638-2792

Childrens Hospital Of La, Los Angeles, California 90027, United States; Recruiting
Kevin Lemley, Site 0001, Phone: 323-361-7299

University Of California Los Angeles, Los Angeles, California 90095, United States; Recruiting
Robert Ettenger, Site 0002, Phone: 310-206-8415

Stanford University Medical Center, Stanford, California 94305, United States; Recruiting
Paul Grimm, Site 0006, Phone: 650-725-5295

Childrens National Medical Center, District of Columbia, District of Columbia 20010, United States; Recruiting
Asha Moudgil, Site 0007, Phone: 202-476-2245

Emory University, Atlanta, Georgia 30322, United States; Recruiting
Barry Warshaw, Site 0012, Phone: 404-712-9923

Boston Childrens Hospital, Boston, Massachusetts 02115, United States; Recruiting
William Harmon, Site 0008, Phone: 617-355-8314

Washington University, St. Louis, Missouri 63110, United States; Recruiting
Vikas Dharnidharka, Site 0003, Phone: 314-747-1349

Children'S Hospital Of Philadelphia, Philadelphia, Pennsylvania 19104, United States; Recruiting
Sandra Amaral, Site 0009, Phone: 267-425-3932

Additional Information

BMS Clinical Trial Information

BMS clinical trial educational resource

Investigator Inquiry form

FDA Safety Alerts and Recalls

Starting date: May 2013
Last updated: August 19, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017