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

• Status: Completed
• Trial end date: 2020-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwestern University
• Collaborator: Novartis
• Treatments: Everolimus; Immunosuppressive Agents; Mycophenolate mofetil; Mycophenolic Acid; Sirolimus; Tacrolimus

Criteria

Inclusion Criteria:

1. Subjects should be adults between 18 and 70 years of age

2. Subjects can be either gender or of any ethnic background

3. Subjects should be single organ recipients (kidney only)

4. Subjects must be able to understand the protocol and provide informed consent.

5. Recipient of living donor kidney transplants

6. Panel reactive antibody (PRA) < 20%

Exclusion Criteria:

1. Subjects with End Stage Renal Disease (ESRD) secondary to primary focal segmental glomerulonephritis (FSGS).

2. Inability to fully understand the purpose of the study and the inability to sign the informed consent

3. Subjects with a significant or active infection

4. Subjects who are pregnant or nursing females

5. Subjects with a history of severe hyperlipidemia not controlled with statins, patients with Cholesterol > 400mg/dl

6. Subjects with a platelet count < 100,000mm3, WBC < 2,000mm3 (or clinical practice)

7. 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.