2026-526938-23-00Not yet recruitingPhase 4
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
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
Source: EU CTIS (euclinicaltrials.eu) · Last updated 19 Oct 2026
Brief summary (registry, in English)
To compare the time-course evolution of lymphocytes in patients receiving Grafalon® versus Thymoglobulin® during the first year post–kidney transplant
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 104 (estimated)
- First submitted
- 20 Jul 2026
- Start date
- 1 Nov 2026
- Lead sponsor
- Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana
- Diseases
- Chronic kidney disease
- EU CT number
- 2026-526938-23-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 104
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people older than 65 who are receiving a kidney transplant with a high risk that the new kidney starts working late. It compares two drugs, Grafalon® and Thymoglobulin®.
- Age
- Older than 65 years
- Sex
- All sexes
- Disease stage
- Receiving a kidney graft at high risk of delayed graft function. Examples: older donor, long cold ischemia time (over 19 hours), retransplant, controlled asystole donor.
- Earlier treatment
- No earlier stem cell transplant or solid organ transplant other than kidney. No perfusion machine used between explant and implant.
- Biomarker or test result
- No donor-specific anti-HLA antibodies in the recipient.
Main reasons for not taking part
- Donor-specific anti-HLA antibodies in the recipient
- Earlier stem cell transplant or solid organ transplant other than kidney
- Active clinically significant bacterial, viral or fungal infection
- Known allergy to Thymoglobulin®, Grafalon®, tacrolimus, mycophenolate, everolimus or prednisone
- Pregnancy or plan to become pregnant during the study
This trial only enrols participants who have had an organ transplant. The registry sentence this rests on: 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
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- 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.
Lab values
- Laboratory abnormalities: WBC <3000×10⁹/L, Neutrophils <1000×10⁹/L, Platelets <100×10⁹/L
Other
- Pregnancy or intention to become pregnant during the study
Who the study is looking for
- 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
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario Dr. Peset Aleixandre | Valencia | Spain | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.