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
Conditions
Interventions
Pharmaceutical Form: Tablet
INN or Proposed INN: VALSARTAN
CAS Number: 137862-53-4
Other descriptive name: valsartan
Concentration unit:
Sponsors
HOSPITAL UNIVERSITARI DE BELLVITGE-IDIBELL
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.; Secondary Objective: 1. Compare the SN-GFR (nephron glomerular filtration rate) 2. 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. 3. To determine the influence of the treatment on podocyturia and the preservation of the number of podocytes at 2 years post transplant. 4. Evaluate the influence of treatment on patient survival, graft, eGFR and proteinuria. 5. Evaluate the influence of treatment on chronic glomerular lesions. 6. Evaluate the safety of the treatment by recording RAGIs (serious and unexpected adverse reactions) and rate of treatment discontinuations. ;Primary end point(s): The main variable will be glomerular filtration rate (GFR) 24 months after transplantation in patients treated with valsartan compared to the group without medication. The measurement of GFR will be carried out by means of iohexol clearance.;Timepoint(s) of evaluation of this end point: 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. STUDY OF THE SINGLE-CELL RNA SEQUENCING 2. CALCULATING THE SN-GFR (GFR for nephron): • CALCULATION OF THE RENAL CORTICAL VOLUME. • MORPHOMETRIC AND STEREOLOGICAL STUDY OF RENAL BIOPSY. • CALCULATION OF THE TOTAL NUMBER OF NEPHRON AND SNGFR. 3. ANALYSIS OF PODOCYTURY AND ESTIMATION OF PODOCYTES IN RENAL BIOPSY. 4. PROTEINURIA, eGFR, SURVIVAL OF THE GRAFT AND THE PATIENT 5. ANALYSIS OF RENAL BIOPSIES 6. EVALUATION OF SAFETY PARAMETERS ;Timepoint(s) of evaluation of this end point: 24 months | — |
Countries
Spain
Contacts
Public ContactCAROLINA POLO
HOSPITAL UNIVERSITARI DE BELLVITGE- IDIBELL
Outcome results
None listed