Renin Angiotensin System Blockade in Renal Transplant Patients With Presence of PECs in Urine

NCT04769778 | Unknown Phase 4

• 1 other identifier: PRONE
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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 renal progenitor cells (PECs) in the urine is able to prevent the expected loss of glomerular filtration (GFR) observed in this subgroup of patients. In addition, investigators intend to deepen the mechanisms of glomerular damage and glomerular repair involved in the process of chronic allograft damage.

Conditions

Chronic Kidney Allograft Nephropathy

Keywords

renin angiotensin; kidney transplant; PEC's

Outcome Measures

Primary Outcomes (1)

• prevention of fall of glomerular filtration rate

  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.

  12 months

Secondary Outcomes (8)

• SN-GFR

  12 months

• Single cell RNA sequencing

  12 months

• podocyturia

  12 months

• graft survival

  12 months

• patient survival

  12 months

Study Arms (2)

Valsartan

EXPERIMENTAL

Treatment with valsartan

Drug: Valsartan 80Mg Oral Tablet

no treatment

NO INTERVENTION

no treatment received

Interventions

Valsartan 80Mg Oral Tablet DRUG

treatment with 80mg /day of valsartan

Valsartan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Josep M Cruzado: lead

Study Sites (1)

Nephrology Department. Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

RECRUITING

MeSH Terms

Interventions

Valsartan; Tablets

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential; Dosage Forms; Pharmaceutical Preparations

Central Study Contacts

JOSEP M CRUZADO, MD, PhD

CONTACT

932607385; jmcruzado@bellvitgehospital.cat

Carolina Polo, PhD

CONTACT

+34 93 260 73 85; cpolo@idibell.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Nephrology

Model Details: Treatment with valsartan versus no treatment

Study Record Dates

• First Submitted: January 7, 2021
• First Posted: February 25, 2021
• Study Start: February 19, 2020
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: May 19, 2021

Record last verified: 2021-05

Locations

ES (1)