N/A N=40 Randomized Treatment

Study in Recipients of Renal Transplant Allograft to Evaluate the Impact of Two Immunosuppressive Regimens

End Stage Renal Failure With Renal Transplant

Bottom Line

View on ClinicalTrials.gov: NCT01653847 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2021

Primary outcome: Primary: Change in T Cell & B Cell Generation — 1.05; 0.93; 0.8; 1.12 Mean % of Treg cells in peripheral blood

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Tacrolimus with MMF (Drug); Group 2: Tacrolimus with Everolimus. (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Northwestern University
Primary completion: May 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in T Cell & B Cell Generation	1.05; 0.93; 0.8; 1.12; 0.81; 1.18	—
PRIMARY Change in Glomerular Filtration Rate (GFR)	63; 66; 64; 64; 65; 72	—
SECONDARY Patient Survival	20; 20	—
SECONDARY Renal Allograft Survival	20; 20	—
SECONDARY Acute Rejection	4; 0	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

Subjects should be adults between 18 and 70 years of age
Subjects can be either gender or of any ethnic background
Subjects should be single organ recipients (kidney only)
Subjects must be able to understand the protocol and provide informed consent.
Recipient of living donor kidney transplants
Panel reactive antibody (PRA) 400mg/dl
Subjects with a platelet count < 100,000mm3, WBC < 2,000mm3 (or clinical practice)
Subjects, who, due to the existence of a surgical, medical or psychiatric condition, other than the current transplant, which in the opinion of the investigator, precludes enrollment into this trial.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01653847). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.