Status:
COMPLETED
Cytokines Evaluation in Early Calcineurin Inhibitors Withdrawn on Renal Transplant
Lead Sponsor:
Andre Barreto Pereira
Collaborating Sponsors:
Novartis
Conditions:
Renal Transplant Rejection
Immunosuppression
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 influenc...
Detailed Description
1. Research objectives OBJECTIVES Main Objectives: • Evaluate the urinary chemokines in kidney transplant patients taking prednisone, tacrolimus and mycophenolate sodium compared to those ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01239472
Start Date
January 1 2011
End Date
June 1 2015
Last Update
February 7 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Santa Casa de Misericórdia de Belo Horizonte
Belo Horizonte, Minas Gerais, Brazil, 30150221