Clinical trial • Not applicable • Nephrology
acetylcysteine, glycine, l-lysine acetate, l-tryptophan, glycyl-tyrosine, l-arginine, l-histidine, l-isoleucine, l-leucine, l-methionine, l-proline, l-serine, l-threonine, l-tyrosine, l-valine, l-phenylalanine, l-alanine for Living donor renal transplantation | Renal transplant
Not applicable trial of acetylcysteine, glycine, l-lysine acetate, l-tryptophan, glycyl-tyrosine, l-arginine, l-histidine, l-isoleucine, l-leucine, l-meth…
Overview
- Trial Therapeutic Area
- Nephrology
- Trial Disease
- Living donor renal transplantation | Renal transplant
- Trial Stage
- Not applicable
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 21-11-2024
- First CTIS Authorization Date
- 09-12-2024
Trial design
open-label, none/not specified-controlled Not applicable trial in Spain.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 60
Eligibility
Recruits 60 Vulnerable population not selected. Psychiatric illness that prevents compliance is an exclusion (evaluation by psychiatrist and psychologist within regular living donor programme). Informed consent required: "Signature of informed consent." No paediatric/assent procedures described (age > 18 required)..
- Pregnancy Exclusion
- 2. Pregnancy and breastfeeding.
- Vulnerable Population
- Vulnerable population not selected. Psychiatric illness that prevents compliance is an exclusion (evaluation by psychiatrist and psychologist within regular living donor programme). Informed consent required: "Signature of informed consent." No paediatric/assent procedures described (age > 18 required).
Inclusion criteria
- {"criterion_text":"- 1. Age > 18 years.\n- 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.\n- 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.\n- 4. Signature of informed consent."}
Exclusion criteria
- {"criterion_text":"- 1. Psychiatric illness that prevents compliance with this protocol (evaluation by psychiatrist and psychologist within the regular living donor programme).\n- 2. Pregnancy and breastfeeding.\n- 3. Inability to understand the protocol and its implications.\n- 4. Cross-transplantation.\n- 5. Transplants whose recipients require prior desensitization protocols.\n- 6. Evidence of allergy to iodine or positive history of previous adverse reactions to contrast media.\n- 7. Medical-surgical contraindications that advise against donation/transplantation and those for intravenous administration of amino acids, according to the technical data sheet.\n- 8. Congenital errors of amino acid metabolism, especially those related to branched-chain amino acids, e.g. isovaleric acidemia.\n- 9. Maple syrup urine disease.\n- 10. Hypersensitivity to one or more of the amino acids present in the solution."}
Endpoints
Primary endpoints
- {"endpoint_text":"- 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.","definition_or_measurement_approach":"Renal function measured with a reference standard: plasma clearance of iohexol. Renal reserve assessed by intravenous infusion of an amino acid solution."}
Recruitment
- Planned Sample Size
- 60
- Recruitment Window Months
- 105
- Consent Approach
- Informed consent is required from each participant: "Signature of informed consent." Separate subject information and informed consent forms exist for donor and organ recipient (documents labelled L1_ES_SIS and ICF donor / organ recipient), indicating materials in Spanish. Participants must be >18 years, so no pediatric assent process is described. Contact/public and scientific contact is the named site contact (Ana González-Rinne).
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 60
Spain
- Earliest CTIS Part Ii Submission Date
- 29-11-2024
- Latest Decision Or Authorization Date
- 09-12-2024
- Processing Time Days
- 10
- Number Of Sites
- 1
- Number Of Participants
- 60
Sites
- Site Name
- University Hospital Of Canary Islands
- Department Name
- Nefrology
- Principal Investigator Name
- Ana González-Rinne
- Principal Investigator Email
- agonrin@gobiernodecanarias.org
- Contact Person Name
- Ana González-Rinne
- Contact Person Email
- agonrin@gobiernodecanarias.org
- Number Of Participants
- 60
Sponsor
Primary sponsor
- Full Name
- University Hospital Of Canary Islands
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- Nephrotect solución para perfusión
- Active Substance
- acetylcysteine, glycine, l-lysine acetate, l-tryptophan, glycyl-tyrosine, l-arginine, l-histidine, l-isoleucine, l-leucine, l-methionine, l-proline, l-serine, l-threonine, l-tyrosine, l-valine, l-phenylalanine, l-alanine
- Modality
- Small molecule
- Routes Of Administration
- INTRAVASCULAR USE
- Route
- INTRAVASCULAR USE
- Authorisation Status
- Authorised (marketing authorisation present in Spain)
- Maximum Dose
- 840 ml
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