Valsartan Treatment Compared in Renal Transplant Recipients with Signs of Post Transplant Glomerulopathy

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Bellvitge University Hospital

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Not possible to specify, Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]

Trial duration

16 Oct 2024 → ongoing

Decision date (initial)

2024-10-16

Transition trial

Yes

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-518723-30-01

EudraCT number

2018-003936-62

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis, Therapy, Efficacy

To evaluate whether treatment with an angiotensin II receptor antagonist (ARB) prevents the drop in glomerular filtration in the subgroup of kidney transplant patients with the presence of PECs in the urine.

Secondary objectives 1

1. 1. Compare the SN-GFR (nephron glomerular filtration rate) of kidney transplant patients with or without PECs in urine and how it varies depending on ARB treatment. 2. Carry out “single cell RNA sequencing” studies using cellular microdissection techniques of PECs cells isolated from kidney biopsies performed at 6 and 24 m after transplant in patients without uPECs and in patients with uPECs included in the therapeutic intervention study. These studies will allow us to know the gene expression changes in PECS cells that may be associated with the favorable response in treated or untreated patients. 3. Determine the influence of treatment on podocyturia and the preservation of the number of podocytes 2 years after transplantation. 4. Evaluate the influence of treatment on patient survival, graft survival, 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.

Conditions and MedDRA coding

Renal transplant patients

Study design 1 period

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Written informed consent.
2. Stable kidney function understood as a variation in eGFR of less than 15% in the last 3 months.
3. Maintenance immunosuppression based on tacrolimus and MMF/MPA.

Exclusion criteria 8

1. Active chronic infection by HCV, HBV, HIV.
2. Treatment with inhibitors of the renin angiotensin system.
3. Double kidney transplant or combined with another organ.
4. Maintenance immunosuppression other than tacrolimus and MMF/MPA. eGFR <20 ml/min/1.73m2.
5. Physically fertile women who plan to become pregnant, are pregnant and/or breast-feeding, or who do not wish to use an effective method of contraception during their participation in the study.
6. Any other medical condition that, in the investigator's judgment, based on the count or review of medical records, could affect the completion of the study, including, but not limited to, visual problems or cognitive impairment. eGFR <20 ml/min/1.73m2.
7. History of allergy or intolerance to renin-angiotensin system inhibitor drugs.
8. eGFR <20 ml/min/1.73m2.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. No primary endpoint

Secondary endpoints 1

1. No secondary endpoint

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bellvitge University Hospital

Sponsor organisation

Bellvitge University Hospital

Address

Carrer De La Feixa Llarga S/N

City

L'Hospitalet De Llobregat

Postcode

08907

Country

Spain

Scientific contact point

Organisation

Bellvitge University Hospital

Contact name

Josep Maria Cruzado Garrit

Public contact point

Organisation

Bellvitge University Hospital

Contact name

Josep Maria Cruzado Garrit

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications