Renin Angiotensin System Blockade in Renal Transplant Patients With Presence of PECs in Urine
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|ClinicalTrials.gov Identifier: NCT04769778|
Recruitment Status : Recruiting
First Posted : February 25, 2021
Last Update Posted : May 19, 2021
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Allograft Nephropathy||Drug: Valsartan 80Mg Oral Tablet||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Treatment with valsartan versus no treatment|
|Masking:||None (Open Label)|
|Official Title:||Renin Angiotensin System Blockade in Renal Transplant Patients With Presence of PECs in Urine|
|Actual Study Start Date :||February 19, 2020|
|Estimated Primary Completion Date :||June 2023|
|Estimated Study Completion Date :||June 2023|
Treatment with valsartan
Drug: Valsartan 80Mg Oral Tablet
treatment with 80mg /day of valsartan
No Intervention: no treatment
no treatment received
- prevention of fall of glomerular filtration rate [ Time Frame: 12 months ]To assess whether treatment with an angiotensin II receptor antagonist (AIIRA) prevents the fall of glomerular filtration in the subgroup of kidney transplant patients with presence of PECs in urine.
- SN-GFR [ Time Frame: 12 months ]Compare the SN-GFR (nephron glomerular filtration rate)
- Single cell RNA sequencing [ Time Frame: 12 months ]Carry out single cell RNA sequencing studies using cell microdissection techniques of PEC cells isolated from renal biopsies performed at 6 and 24 m after transplantation in patients without uPECs and in patients with uPECs included in the therapeutic intervention study. These studies will allow us to know the changes of gene expression in PECS cells that can be associated with the favorable response in treated or untreated patients.
- podocyturia [ Time Frame: 12 months ]To determine the influence of the treatment on podocyturia and the preservation of the number of podocytes at 2 years post transplant.
- graft survival [ Time Frame: 12 months ]Evaluate the influence of treatment on graft survival
- patient survival [ Time Frame: 12 months ]Evaluate the influence of treatment on patient survival and proteinuria.
- Chronic Glomerular Lessions [ Time Frame: 12 months ]Evaluate the influence of treatment on number of participants with chronic glomerular lesions.
- Suspected Unexpected Serious Adverse Reaction (SUSAR) reporting unexpected serious adverse reactions) [ Time Frame: 12 months ]Evaluate the safety of the treatment on the number of patients with Suspected Unexpected Serious Adverse Reaction (SUSAR) reporting unexpected serious adverse reactions) unexpected adverse reactions) and rate of treatment discontinuations.
- Proteinuria [ Time Frame: 12 months ]Evaluate the influence of treatment on measure of proteinuria
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04769778
|Contact: JOSEP M CRUZADO, MD, PhDemail@example.com|
|Contact: Carolina Polo, PhD||+34 93 260 73 firstname.lastname@example.org|