Overview
Sponsor-declared trial summary
Renal Transplantation, living donor
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.
Key facts
- Sponsor
- University Hospital Of Canary Islands
- Participant type
- Healthy volunteers, Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01], Not possible to specify
- Decision date (initial)
- 2024-12-09
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Universitary Hospital of Canary Island
External identifiers
- EU CT number
- 2024-519757-11-00
- EudraCT number
- 2018-001710-15
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis
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.
Secondary objectives 1
- To analyse the ability of indirect methods of estimating renal function such as formulas or 24-hour urine clearance in the assessment of renal reserve and the evolution of renal function before and after transplantation.
Conditions and MedDRA coding
Renal Transplantation, living donor
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10038533 | Renal transplant | 100000004865 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | PREDONATION KIDNEY RESERVE IMPACT ON THE EVOLUTION OF DONOR AND RECIPIENT RENAL FUNCTION IN A LIVING DONOR RENAL TRANSPLANTATION PROGRAMME
|
2 | None |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 1. Age > 18 years. 2. 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. 3. 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. 4. Signature of informed consent.
Exclusion criteria 1
- 1. Psychiatric illness that prevents compliance with this protocol (evaluation by psychiatrist and psychologist within the regular living donor programme). 2. Pregnancy and breastfeeding. 3. Inability to understand the protocol and its implications. 4. Cross-transplantation. 5. Transplants whose recipients require prior desensitization protocols. 6. Evidence of allergy to iodine or positive history of previous adverse reactions to contrast media. 7. Medical-surgical contraindications that advise against donation/transplantation and those for intravenous administration of amino acids, according to the technical data sheet. 8. Congenital errors of amino acid metabolism, especially those related to branched-chain amino acids, e.g. isovaleric acidemia. 9. Maple syrup urine disease. 10. Hypersensitivity to one or more of the amino acids present in the solution.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Nephrotect solución para perfusión
PRD2057894 · Product
- Active substance
- Acetylcysteine
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVASCULAR USE
- Max daily dose
- 840 ml millilitre(s)
- Max total dose
- 840 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05BA01 — AMINO ACIDS
- Marketing authorisation
- 67.038
- MA holder
- FRESENIUS KABI DEUTSCHLAND GMBH
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
University Hospital Of Canary Islands
- Sponsor organisation
- University Hospital Of Canary Islands
- Address
- Carretera De La Cuesta Taco S/n, Cuesta La Cuesta La
- City
- San Cristobal De La Laguna
- Postcode
- 38320
- Country
- Spain
Scientific contact point
- Organisation
- University Hospital Of Canary Islands
- Contact name
- Ana González Rinne
Public contact point
- Organisation
- University Hospital Of Canary Islands
- Contact name
- Ana González Rinne
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 60 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2018-001710-15 | 5 |
| Recruitment arrangements (for publication) | Document 1 | 1 |
| Subject information and informed consent form (for publication) | L1_ES_SIS and ICF donor | 1 |
| Subject information and informed consent form (for publication) | L1_ES_SIS and ICF organ recipient | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ SmPC_Nephrotect | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-21 | Spain | Acceptable 2024-12-09
|
2024-12-09 |