Comparison of NODAT in Kidney Transplant Patients Receiving Belatacept Versus Standard Immunosuppression

Kidney Transplantation Clinical Trial

Official title:

Open-Label, Randomized Comparison of NODAT in Renal Transplant Patients Receiving a Nulojix (Belatacept) Regimen Versus Standard Therapy Immunosuppression

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01875224
• Other study ID #: IM103-303
• Status: Not yet recruiting
• Phase: Phase 4
• First received: May 29, 2013
• Last updated: June 7, 2013
• Start date: August 2013
• Est. completion date: August 2016

Study information

• Verified date: June 2013
• Source: University of Arizona
• Contact: Bruce Kaplan, MD
• Phone: 520-626-6371
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is being conducted to determine if belatacept is an appropriate alternative immunosuppressive medication (reducing the immune system's effect) when a kidney transplant patient develops new onset diabetes after transplant (NODAT). Patients who are diagnosed with NODAT will be approached with the opportunity to participate in this study. If they agree to participate, they will be randomized one-to-one (like a coin flip) to the study arm (belatacept) or the control arm (their current medication regimen). If a patient is randomized to the study arm, they will be tapered off of their current regimen when they have started receiving their monthly belatacept infusions. The control arm will mean the patient will continue their current, standard of care medications, but following the tacrolimus trough levels indicated within the study protocol. Different laboratory tests (i.e. fasting blood glucose) will be measured during the study to monitor the progression of NODAT in all patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Written informed consent must be given by patient.

• Adult patients between age 18 and 65

• Thymoglobulin induction at the time of transplant

• Patient must be Epstein-Barr Virus seropositive

Exclusion Criteria:

• Patient who received an blood type incompatible transplant, or with T-cell or B-cell positive crossmatch

• Patients with Hepatitis B, Hepatitis C, HIV or a clinically significant systemic infection within 30 days prior to transplant

• History of stroke, severe cardiac disease or cardiac failure

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Kidney Transplantation
• New Onset Diabetes After Transplant

Intervention

Drug:
• Belatacept

• Tacrolimus
Standard administration of tacrolimus

Locations

Country	Name	City	State
United States	University of Arizona	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
University of Arizona	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increased insulin sensitivity	Increase in insulin sensitivity (HOMA-S) as calculated below: FIRI = fasting plasma insulin level; FPG = fasting plasma glucose level; HOMA-S (insulin sensitivity) is calculated as 22.5 / (FIRI * FPG)	12 months	No
Primary	Decreased insulin resistance	Decreased insulin resistance (HOMA-IR) as measured below: FIRI = fasting plasma insulin level; FPG = fasting plasma glucose level; HOMA IR (insulin resistance) is calculated as (FIRI * FPG) / 22.5	12 months	No