Cytokines Evaluation in Early Calcineurin Inhibitors Withdrawn on Renal Transplant

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Currently, acute kidney injury is diagnosed by increased serum creatinine. However, creatinine is not a reliable marker for acute changes in renal function.

The biology of the renal graft is influenced by chemokines from reperfusion (just after the kidney transplant) and throughout its course, when acute and chronic inflammatory changes occurs. Moreover, the evaluation of changes in urinary cytokines reflects kidney interstitial patterns, and can predict renal function, acute rejection episodes and their response to treatment.

Today there are several studies comparing the relative immunosuppression of renal function, but few noticed its relationship with cytokines and chemokines. Thus, we proposed studying the inflammatory consequences of early calcineurin inhibitors (ICN) withdrawing in transplant patients by urine analysis. Kidney biopsy was done before ICN withdrawn and replaced by everolimus (3 months after transplant), and 1 year after transplant.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Andre Barreto Pereira
• Collaborator: Novartis
• Treatments: Calcineurin Inhibitors; Everolimus; Mycophenolate mofetil; Mycophenolic Acid; Prednisone; Sirolimus; Tacrolimus

Criteria

Inclusion Criteria:

• Patients over 18 years old and under 65 years old

• Recipients of first kidney transplant

• Donor younger than 65 years old

• PRA (panel reactive antigen) ≤ 30% in class I or class II

• No acute rejection episodes

• Proteinuria <1000 mg / day

Exclusion Criteria:

• multiple organ transplant recipient

• Chronic liver failure

• Asymptomatic bacteriuria or urinary infection at randomization time

• Creatinine ≥ 2 mg / dL at randomization time (90 days after transplant)

• Presence of uncontrolled hypercholesterolemia (≥ 350 mg / dL, ≥ 9.1 mmol / L) or hypertriglyceridemia (≥ 500 mg / dL, ≥ 5.6 mmol / L) at randomization time (90 days after transplant)