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Clinical Trials/2024-519757-11-00
2024-519757-11-00
Not yet recruiting
Phase 3

PREDONATION KIDNEY RESERVE: IMPACT IN THE EVOLUTION OF DONOR AND RECIPIENT RENAL FUNCTION IN A RENAL TRANSPLANTATION PROGRAMME OF LIVING DONOR

University Hospital Of Canary Islands1 site in 1 country60 target enrollmentStarted: December 9, 2024Last updated:
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Overview

Phase
Phase 3
Status
Not yet recruiting
Sponsor
University Hospital Of Canary Islands
Enrollment
60
Locations
1
Primary Endpoint
Renal function evolution measured in the donor and recipient after renal transplantation. Renal function will be measured with a reference standard, plasma clearance of iohexol. Renal reserve will be assessed by intravenous infusion of an amino acid solution.
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

To evaluate the evolution of post-transplant renal function in living donor transplant donors and recipients in relation to renal function and renal reserve of the donor before transplantation.

Study Design

Allocation
Non-randomized
Primary Purpose
Predonation Kidney Reserve
Masking
None

Eligibility Criteria

Ages
18 years to 65+ years (65+ Years, 18-64 Years)
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Age > 18 years.
  • •Subjects (donor-recipient) referred to the Nephrology Service for inclusion in the living donor renal transplant programme and in whom no contraindication for donation/transplant has been detected.
  • •Clinical stability, defined by the absence of intercurrent episodes during the last month, such as: acute infections, acute renal failure of any aetiology, cardiovascular disease, etc.
  • •Signature of informed consent.

Exclusion Criteria

  • •Psychiatric illness that prevents compliance with this protocol (evaluation by psychiatrist and psychologist within the regular living donor programme).
  • •Pregnancy and breastfeeding.
  • •Inability to understand the protocol and its implications.
  • •Cross-transplantation.
  • •Transplants whose recipients require prior desensitization protocols.
  • •Evidence of allergy to iodine or positive history of previous adverse reactions to contrast media.
  • •Medical-surgical contraindications that advise against donation/transplantation and those for intravenous administration of amino acids, according to the technical data sheet.
  • •Congenital errors of amino acid metabolism, especially those related to branched-chain amino acids, e.g. isovaleric acidemia.
  • •Maple syrup urine disease.
  • •Hypersensitivity to one or more of the amino acids present in the solution.

Outcomes

Primary Outcomes

Renal function evolution measured in the donor and recipient after renal transplantation. Renal function will be measured with a reference standard, plasma clearance of iohexol. Renal reserve will be assessed by intravenous infusion of an amino acid solution.

Renal function evolution measured in the donor and recipient after renal transplantation. Renal function will be measured with a reference standard, plasma clearance of iohexol. Renal reserve will be assessed by intravenous infusion of an amino acid solution.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
University Hospital Of Canary Islands
Sponsor Class
Hospital/Clinic/Other health care facility
Responsible Party
Principal Investigator
Principal Investigator

Ana González Rinne

Scientific

University Hospital Of Canary Islands

Study Sites (1)

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