Efficacy and safety of Grafalon® versus Thymoglobulin® for induction therapy in kidney transplant recipients at high risk of delayed graft function: a phase IV randomized open-label study
Key facts
- Where
- Valencia, SpanyolországSee the site
- Phase
- 4. fázis
Where in Spanyolország
- Hospital Universitario Dr. Peset AleixandreValencia, SpanyolországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana
- Trial code
- EU 2026-526938-23-00
- Record updated
- 2026. október 19.
- Original description
To compare the time-course evolution of lymphocytes in patients receiving Grafalon® versus Thymoglobulin® during the first year post–kidney transplantRead full original descriptionShow less
Phase IV, randomized, open-label study comparing the use of Grafalon® versus Thymoglobulin® in non-sensitized patients who have received a kidney transplant at high risk of delayed graft function
To compare the time-course evolution of lymphocytes in patients receiving Grafalon® versus Thymoglobulin® during the first year post–kidney transplant
Inclusion: Older than 65 years; Signed informed consent; Patients receiving a kidney graft at high risk of delayed graft function, defined as: - expanded criteria donors (>60 years, or >50 years plus one of: hypertension, diabetes mellitus, Creatinine > or equal 1.5 mg/dL, death by stroke) - Prolonged ICU stay (4-5 days, hemodynamic instability) - cold ischemia time > 19 hours, acute renal failure in donor - pediatric en bloc donors - Retransplants - Low immunological risk recipients without HLA incompatibility - Controlled asystole donors.
Exclusion: Recipient with donor-specific anti-HLA antibodies; Use of perfusion machine between explant and implant; Prior hematopoietic stem cell or solid organ transplant (except kidney); Any other medical or social condition that renders the patient unsuitable for participation or completion of the full study period; Patients at risk of recurrent atypical hemolytic uremic syndrome requiring C5 inhibitor prophylaxis; Active clinically significant bacterial, viral, or fungal infection; Known hypersensitivity to tacrolimus, mycophenolate mofetil/mycophenolic acid, mTOR inhibitors (everolimus), or prednisone; Known hypersensitivity to Thymoglobulin® or Grafalon® or any of their excipients; Laboratory abnormalities: WBC <3000×10⁹/L, Neutrophils <1000×10⁹/L, Platelets <100×10⁹/L; Pregnancy or intention to become pregnant during the study.