Clinical trial • Phase IV • Other

VALSARTAN for Kidney transplant recipients | Post-transplant glomerulopathy

Phase IV trial of VALSARTAN for Kidney transplant recipients | Post-transplant glomerulopathy.

Overview

Trial Therapeutic Area
Other
Trial Disease
Kidney transplant recipients | Post-transplant glomerulopathy
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
16-10-2024
First CTIS Authorization Date
16-10-2024

Trial design

Randomised, open-label, placebo (control group); valsartan 80 mg (investigational product, oral) — schedule not specified Phase IV trial across 1 site in Spain.

Randomised
Yes
Open Label
Yes
Comparator
Placebo (control group); Valsartan 80 mg (investigational product, oral) — schedule not specified
Biomarker Stratified
True, biomarker: renal progenitor cells in urine (PECs / uPECs); strata: presence vs absence of uPECs
Target Sample Size
180

Eligibility

Recruits 180 No vulnerable populations selected; informed consent required: 'Written informed consent.'.

Pregnancy Exclusion
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.
Vulnerable Population
No vulnerable populations selected; informed consent required: 'Written informed consent.'

Inclusion criteria

  • {"criterion_text":"- Written informed consent."}
  • {"criterion_text":"- Stable kidney function understood as a variation in eGFR of less than 15% in the last 3 months."}
  • {"criterion_text":"- Maintenance immunosuppression based on tacrolimus and MMF/MPA."}

Exclusion criteria

  • {"criterion_text":"- Active chronic infection by HCV, HBV, HIV."}
  • {"criterion_text":"- Treatment with inhibitors of the renin angiotensin system."}
  • {"criterion_text":"- Double kidney transplant or combined with another organ."}
  • {"criterion_text":"- Maintenance immunosuppression other than tacrolimus and MMF/MPA. eGFR <20 ml/min/1.73m2."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- History of allergy or intolerance to renin-angiotensin system inhibitor drugs."}
  • {"criterion_text":"- eGFR <20 ml/min/1.73m2."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- No primary endpoint","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- No secondary endpoint","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
180
Recruitment Window Months
86
Consent Approach
Written informed consent required. Subject information and informed consent form document listed (ICF PRONE version 2). No details provided in the record about assent, age-specific consent documents, or available languages.

Geography

Total Number Of Sites
1
Total Number Of Participants
180

Spain

Earliest CTIS Part Ii Submission Date
16-10-2024
Latest Decision Or Authorization Date
16-10-2024
Number Of Sites
1
Number Of Participants
180

Sites

Site Name
Bellvitge University Hospital
Department Name
Nephrology and Renal Transplant
Principal Investigator Name
Josep Maria Cruzado Garrit
Principal Investigator Email
jmcruzado@bellvitgehospital.cat
Contact Person Name
Josep Maria Cruzado Garrit

Sponsor

Primary sponsor

Full Name
Bellvitge University Hospital
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Spain

Investigational products

Investigational Product Name
Valsartan STADA 80 mg Filmtabletten
Active Substance
VALSARTAN
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Authorised (marketing authorisation present: AT/H/0264/002)
Starting Dose
80 mg
Dose Levels
80 mg (max daily dose 160 mg)
Maximum Dose
160 mg

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