Switch From Calcineurin Inhibitor to Belatacept in Pancreas Transplant Recipients

NCT02103855 | Completed Phase 4 Results DMC

• 1 other identifier: BMS 103-337
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Kidney damage is a major complication of current antirejection medicines used in transplantation. An increasing number of brittle diabetics are successfully receiving a pancreas transplant. One of the challenges following pancreas transplant is that a patient can develop kidney damage from one of their antirejection medicines, tacrolimus. The objective of this study is to substitute a new antirejection medicine which does not cause kidney damage, belatacept for tacrolimus in patients that have developed signs of tacrolimus related kidney damage to slow the progression of kidney disease.

Conditions

Nephrotoxicity

Keywords

pancreas transplantation; immunosuppression; belatacept

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Serum Estimated Glomerular Filtration Rate (eGFR)

  Change in serum eGFR from baseline to 1 year following conversion from tacrolimus to belatacept

  Baseline and 1 year

• Serum Creatinine at Year 1

  Serum Creatinine measured at 1 year after conversion from Tacrolimus to Belatacept.

  1 year

Secondary Outcomes (3)

• Number of Participants With Pancreas Transplant Rejection

  1 year

• Change From Baseline Serum Hemoglobin A1c

  Baseline and 1 year

• Pancreas Transplant Function as Measured by Fasting Serum Glucose Level.

  1 Year

Study Arms (1)

belatacept

EXPERIMENTAL

Belatacept 5 mg/kg IVPB q 2 wks x 5 doses followed by 5 mg/kg IVPB q month. The belatacept dose will be infused IV over 30 minutes. Day 14: Reduce tacrolimus dose by 25% Day 30: Reduce tacrolimus dose by additional 25% Day 45: Reduce tacrolimus dose by additional 25% Day 60: Stop tacrolimus.

Drug: Belatacept

Interventions

Belatacept DRUG

Also known as: Nulojix

belatacept

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pancreas transplant alone recipients
• EBV IgG positive
• Biopsy proven calcineurin inhibitor toxicity on native kidney biopsy
• Maintained on a regimen of tacrolimus, sirolimus, mycophenolate

You may not qualify if:

• EBV IgG negative
• Not maintained on an immunosuppression regimen that contains tacrolimus
• Unable or unwilling to give informed consent
• Active infection
• History of malignancy post transplant
• Glomerular filtration rate \< 15 mL/min

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Health, University Hospital

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Interventions

Abatacept

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins

Results Point of Contact

• Title: Jeanne Chen
• Organization: Indiana University

jchen@iuhealth.org

317-944-3570

Study Officials

• Asif Sharfuddin, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asif A Sharfuddin, MD

Study Record Dates

• First Submitted: April 1, 2014
• First Posted: April 4, 2014
• Study Start: June 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: August 28, 2017
• Results First Posted: August 28, 2017

Record last verified: 2017-08

Locations

US (1)