Who is sponsoring NCT01653847?

NCT01653847 is sponsored by Northwestern University.

What condition does NCT01653847 study?

NCT01653847 studies End Stage Renal Failure With Renal Transplant.

What drugs are being tested in NCT01653847?

Interventions: Tacrolimus with MMF, Group 2: Tacrolimus with Everolimus..

What is the status of NCT01653847?

NCT01653847 is currently COMPLETED.

Last reviewed 2021-02-10 · How we verify

Impact of Two Prednisone-free Maintenance Immunosuppressive Regimens With Reduced Dose FK506+Everolimus vs. Standard Dose Tacrolimus (FK506)+ Mycophenolate Mofetil (MMF) on Subpopulation of T and B Cells, Renal Allograft Function and Gene Expression Profiles in Renal Allograft Biopsies at 12 Months Post-transplant. Prospective Single Center Study in Recipients of Renal Transplant Allograft.

NCT01653847 NA COMPLETED Results posted

The immune system is the body's defense against infection and other disease. After transplantation, the body sees the new organ as "foreign" and tries to destroy or "reject" it. Immunosuppressive medications help to prevent the immune system from attacking a transplanted organ. The primary purpose of this study is to investigate the impact of two maintenance immunosuppressive regimens. Subjects who enroll in this study will be randomly selected to have tacrolimus and everolimus (group 1) or tacrolimus and mycophenolate mofetil (group 2) as their immunosuppression medication. This study will enroll adult patients who are scheduled to receive a kidney transplant. The study is designed to understand the mechanisms of Everolimus in regards to kidney function in transplant recipients. The investigators hypothesis is that decreased exposure to Tacrolimus to the immune system will then translate in better renal allograft function.

Details

Lead sponsor	Northwestern University
Phase	NA
Status	COMPLETED
Enrolment	88
Start date	2013-02
Completion	2020-05

Conditions

End Stage Renal Failure With Renal Transplant

Interventions

Tacrolimus with MMF
Group 2: Tacrolimus with Everolimus.

Primary outcomes

Change in T Cell & B Cell Generation — Baseline, 3 months, and 12 months post-transplant
Evaluate the change in regulatory T cell generation and review the relationship of the newly generated T cells with their function in the two maintenance immunosuppressive regimens at baseline, 3 and 12 months post-transplant.
Change in Glomerular Filtration Rate (GFR) — 3 months, 6 months, and 12 months post-transplant
Evaluate the change in graft function (as measured by GFR) at 12 months post-transplant from baseline.

Countries

United States