VALSARTAN TREATMENT COMPARED IN RENAL TRANSPLANT RECIPIENTS WITH SIGNS OF POST TRANSPLANT GLOMERULOPATHY

Phase 1

• Conditions: POST TRANSPLANT RENAL GLOMERULOPATHY; MedDRA version: 20.0 Level: PT Classification code 10038533 Term: Renal transplant System Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 20.1 Level: LLT Classification code 10063210 Term: Transplant glomerulopathy System Organ Class: 100000004870; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2018-003936-62-ES
• Lead Sponsor: HOSPITAL UNIVERSITARI DE BELLVITGE-IDIBE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-12
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 180

Inclusion Criteria

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

Exclusion Criteria

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.
eGFR <20 ml / min / 1.73m2.
History of allergy or intolerance to inhibitors of the renin angiotensin system.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified