Pharmacokinetics, Safety and Tolerability of Single-dose Belatacept in Adolescent Kidney Transplant Recipients

Kidney Transplant Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01791491
• Other study ID #: IM103-144
• Secondary ID: 2011-005257-31
• Status: Completed
• Phase: Phase 2
• First received: January 31, 2013
• Last updated: March 3, 2017
• Start date: May 2013
• Est. completion date: December 2016

Study information

• Verified date: January 2016
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate how well adolescent kidney transplant patients tolerate a single dose of belatacept they receive at least 6 months after transplant surgery, and how their body handles the drug.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Inclusion Criteria:

• Male and Female subjects,12-17 years old

• Receiving CNI-based maintenance immunosuppression since the time of renal transplantation in accordance with local standard of care

• Stable renal function, in the opinion of the investigator, with a cGFR>45 mL/min/1.73m2 at the time of enrollment (per updated Schwartz Formula)

• Adolescent 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 may be receiving maintenance corticosteroids in accordance with the local standard of care

• Negative Interferon Gamma Release Assay (IGRA) such as QuantiFERON-TB Gold test or T-Spot-TB

• FOCBP must have negative serum or urine pregnancy test within 24 hrs prior to start of study medication

• 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 enrollment

• 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

Related Conditions & MeSH terms

• Kidney Transplant

Intervention

Drug:
• Belatacept
Single intravenous infusion of belatacept, 7.5 mg/kg

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	University Of Alabama At Birmingham	Birmingham	Alabama
United States	Local Institution	Boston	Massachusetts
United States	Childrens National Medical Center	District of Columbia	District of Columbia
United States	Local Institution	Los Angeles	California
United States	University Of California Los Angeles	Los Angeles	California
United States	Washington University	St. Louis	Missouri
United States	Local Institution	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of maximum observed serum concentration (Tmax)		7 time points following SD administration up to Day 57
Primary	Maximum observed serum concentration (Cmax)		7 time points following SD administration up to Day 57
Primary	Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]		7 time points following SD administration up to Day 57
Primary	Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)]		7 time points following SD administration up to Day 57
Primary	Half-life (T-HALF)		7 time points following SD administration up to Day 57
Primary	Total body clearance (CLT)		7 time points following SD administration up to Day 57
Primary	Volume of distribution at steady-state (Vss)		7 time points following SD administration up to Day 57
Secondary	Safety will be measured by proportion of subjects reporting Adverse Event (AE), Serious AE, and AE leading to early discontinuation		BL/Day 1, Days 8, 15, 29 and 57, Week 24
Secondary	Antibody titers against Belatacept		Day 1, 15, 29, and 57 in SD phase
Secondary	CD86 receptor occupancy in Blood samples		Day1, 29 and 57 in SD phase
Secondary	Tolerability will be measured by proportion of subjects reporting Adverse Event (AE), Serious AE, and AE leading to early discontinuation		BL/Day 1, Days 8, 15, 29 and 57, Week 24

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry form