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Study of anti‑T lymphocyte immunoglobulin (rabbit) in non‑sensitized kidney transplant recipients at high risk of delayed graft function

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

Patients with Chronic Kidney Disease who undergo Kidney transplantation sometimes experience delayed graft function, a condition where the new kidney does not start working right away after the operation. To help prevent the body’s immune system from attacking the transplanted organ, two medicines are being studied: Grafalon and Thymoglobulin. Both are given by an intravenous (IV) infusion shortly before or after the transplant and work by lowering certain immune cells.

The purpose of the study is to compare how the number of lymphocytes, a type of white‑blood cell that plays a key role in the immune response, changes over the first year after the transplant when patients receive either of the two medicines. Participants are randomly assigned to receive one of the drugs, get the infusion around the time of their transplant, and then have regular check‑ups and blood tests for up to twelve months.

During the follow‑up period, blood samples are taken at scheduled visits to monitor lymphocyte counts, overall blood health, kidney function, and any signs of infection or other problems. Any serious side effects, infections, or need to stop the medication are recorded, and the study continues until the one‑year follow‑up is completed.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization and Assignment to Treatment Arm

    After joining the study, you will be randomly placed into one of two groups. One group receives Grafalon and the other receives Thymoglobulin. Random assignment ensures that the comparison of the two medicines is fair.

  2. Step 2

    Administration of Induction Medication

    Within the first days after your kidney transplant, you will receive an intravenous infusion (a medication delivered through a vein).

    If you are assigned to the Grafalon group, the dose is 3 milligrams per kilogram of body weight (3 mg/kg).

    If you are assigned to the Thymoglobulin group, the dose is 1.25 milligrams per kilogram of body weight (1.25 mg/kg).

    The infusion is given as a single treatment, and the medical team will monitor you closely during and after the infusion.

  3. Step 3

    Immediate Post‑Infusion Monitoring

    After the infusion, you will stay in the hospital for observation. Vital signs such as heart rate, blood pressure, and temperature are checked regularly.

    Blood samples are taken to assess early changes in lymphocyte counts and other laboratory values.

  4. Step 4

    Discharge and Continuation of Standard Immunosuppression

    When the medical team determines that you are stable, you will be discharged home.

    You will continue the usual medicines that prevent rejection of the transplanted kidney. These are not part of the study drug but are required for standard care.

  5. Step 5

    Scheduled Follow‑Up Visits and Laboratory Assessments

    Throughout the first year after transplantation, you will attend regular clinic visits. At each visit, blood is drawn to measure lymphocyte levels, hemoglobin, white‑blood‑cell counts, neutrophils, and platelets.

    The schedule typically includes more frequent visits during the first month (for example, weekly) and then monthly visits up to 12 months, although exact timing is determined by the study protocol.

    These laboratory tests help the researchers understand how the two medicines affect your immune system over time.

  6. Step 6

    Monitoring for Infections and Rejection

    You will be asked to report any signs of infection such as fever, cough, urinary symptoms, or wound problems.

    If an infection occurs, the study team may prescribe treatments such as granulopoietic colony‑stimulating factors (medicines that help increase white‑blood‑cell counts).

    The team also watches for signs of kidney rejection, both cellular and antibody‑mediated, and will record any episodes that happen during the study period.

  7. Step 7

    Adjustment of Study Medication or Other Treatments If Needed

    If you experience serious side effects from the study drug, the investigators may reduce or stop the medication and adjust your other treatments accordingly.

    Any changes to your maintenance immunosuppression or prophylactic medications are documented as part of the study.

  8. Step 8

    Final Assessment at One Year

    At the end of the 12‑month follow‑up period, you will have a final clinic visit. Blood tests will be performed to evaluate the long‑term effect of the assigned medication on your immune system and kidney function.

    The study concludes after this final assessment, and the collected data are used to compare the safety and effectiveness of Grafalon versus Thymoglobulin.

Who can join the trial?

10 criteria

  • Be older than 65 years.
  • Sign a written informed consent form, which means you agree to join the study after understanding what will happen.
  • Receive a kidney transplant that is considered at high risk for delayed graft function (the new kidney may not start working right away). This high‑risk status includes any of the following conditions:
  • Have a donor kidney that meets the definition of an expanded criteria donor, meaning the donor is older than 60 years, or older than 50 years with at least one of these conditions: high blood pressure (hypertension), diabetes (diabetes mellitus), a blood test called creatinine of 1.5 mg/dL or higher, or death from stroke.
  • Have a donor who spent a long time (4‑5 days) in the intensive care unit (ICU) with unstable blood pressure or heart function (hemodynamic instability).
  • Have a donor kidney that was kept cold for more than 19 hours before transplantation (cold ischemia time), or the donor had sudden kidney failure (acute renal failure).
  • Have a donor who was a child and whose kidneys were transplanted together as a pair (pediatric en bloc donor).
  • Be receiving a repeat kidney transplant (retransplant).
  • Be a patient with a low chance of immune rejection because there is no mismatch in tissue type markers (HLA incompatibility).
  • Have a donor who experienced a controlled pause in heart activity after death (controlled asystole donor).

Who cannot join the trial?

10 criteria

  • Having donor‑specific anti‑HLA antibodies, which are immune proteins that can attack the donated kidney.
  • Any other medical or social condition that makes it unsafe for you to join or finish the study.
  • Having used a perfusion machine to keep the kidney alive between its removal and implantation.
  • Having had a previous bone‑marrow (hematopoietic stem cell) transplant or any organ transplant other than a kidney.
  • Having certain lab results that are too low: white blood cells under 3,000, neutrophils under 1,000, or platelets under 100,000 (these are cells that help fight infection and stop bleeding).
  • Being at risk for a repeat of atypical hemolytic uremic syndrome that would need a medication called a C5 inhibitor to prevent it.
  • Having an active infection that is a significant bacterial, viral, or fungal illness.
  • Being known to be allergic (hypersensitive) to any of these transplant medicines: tacrolimus, mycophenolate mofetil/mycophenolic acid, everolimus (a type of mTOR inhibitor), or prednisone.
  • Being known to be allergic (hypersensitive) to Thymoglobulin®, Grafalon®, or any of their ingredients.
  • Being pregnant or planning to become pregnant while the study is being done.
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Investigated drugs

  • Thymoglobulin

    is a medication made from rabbit antibodies that target T‑lymphocytes, which are a type of white blood cell that can cause the body to reject a new kidney. In this study, it is given through an IV infusion after the kidney transplant to lower the activity of these cells, helping to reduce the risk of the transplanted kidney not working well right away (delayed graft function) and to prevent early rejection.

  • Grafalon

    is another medication that contains rabbit antibodies against T‑lymphocytes, working in much the same way as Thymoglobulin. It is also given by IV infusion after the kidney transplant. The purpose of Grafalon in the trial is to suppress the immune response that could damage the new kidney, aiming to improve how quickly the kidney starts working and to lower the chance of early rejection.

What is already known about the treatment

  • Thymoglobulin

    Thymoglobulin is supplied as a sterile powder that is mixed to make a solution for infusion and is given by intravenous injection. It is an approved medication that has been used for many years in kidney and other organ transplants and is well documented in medical literature. The drug is mainly used to prevent rejection of a transplanted kidney by lowering the number of T‑lymphocytes, the immune cells that can attack the new organ. Thymoglobulin belongs to the antithymocyte immunoglobulin class, an immunosuppressant that works by binding to T‑cells and blocking their activity.

  • Grafalon

    Grafalon is provided as a concentrated solution for infusion and is administered intravenously during a transplant procedure. It is also an approved antithymocyte immunoglobulin that has been extensively studied and is widely used in clinical practice for organ transplantation. The medication helps prevent kidney‑transplant rejection by reducing the activity of T‑lymphocytes, the immune cells responsible for attacking the graft. Grafalon is classified as a rabbit‑derived antithymocyte immunoglobulin, a type of immunosuppressive drug that attaches to T‑cells and inhibits their function.

Investigated diseases

  • Chronic Kidney Disease

    A long‑term condition in which the kidneys gradually lose their ability to filter waste and excess fluid from the blood. Over months to years the filtration rate declines, leading to accumulation of waste products and changes in fluid balance. The disease is often staged based on how much kidney function remains. As it progresses, the kidneys become less able to regulate electrolytes, blood pressure, and acid‑base balance. Patients may notice swelling, fatigue, or changes in urine output as the condition advances.

  • Kidney transplantation

    A surgical procedure that replaces a failing kidney with a healthy donor kidney. After the operation the new organ begins to filter blood, restoring many kidney functions that were lost. The transplanted kidney initially undergoes a period of adaptation as it establishes blood flow and filtration. Over time the graft can continue to function for many years, providing improved waste removal and fluid regulation. Monitoring is required to ensure the graft remains healthy and to detect any complications early.

Trial detailsLast updated 21 Oct 2026
Age65+ yearsPhasePhase IIITrial ID2026-526938-23-00Protocol codeGRAFAVSTIMOEstimated enrolment104 patientsSponsorFundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana

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