Status:
UNKNOWN
Renin Angiotensin System Blockade in Renal Transplant Patients With Presence of PECs in Urine
Lead Sponsor:
Josep M Cruzado
Conditions:
Chronic Kidney Allograft Nephropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
By means of a personalized medicine strategy, investigators are going to evaluate if the treatment with an angiotensin II receptor antagonist (ARAII) in renal transplant patients with the presence of ...
Detailed Description
A randomized, double-blind clinical trial will be performed in renal transplant patients in month 6 post-transplant, at the time of protocol renal biopsy. After verifying the inclusion and exclusion c...
Eligibility Criteria
Inclusion
- Written informed consent
- Stable renal function understood as a variation of eGFR of less than 15% in the last 3 months
- Immunosuppression maintenance based on tacrolimus and MMF / MPA
Exclusion
- Chronic active infection by HCV, HBV, HIV.
- Treatment with inhibitors of the renin angiotensin system.
- Double kidney transplant or combined with another organ.
- Immunosuppression of maintenance other than tacrolimus and MMF / MPA.
- eGFR \<20 ml / min / 1.73m2.
- History of allergy or intolerance to inhibitors of the renin angiotensin system.
- Physically fertile women who plan to become pregnant, are pregnant and
- / or breast-feeding, or who do not want to use effective contraception during their participation in the study.
- Any other medical condition that, in the opinion of the investigator, based on the counting or review of clinical records, could affect the completion of the study, including, but not limited to, visual problems or cognitive impairment.
Key Trial Info
Start Date :
February 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2023
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT04769778
Start Date
February 19 2020
End Date
June 1 2023
Last Update
May 19 2021
Active Locations (1)
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1
Nephrology Department. Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907