Can a Single-Day infusion save transplanted kidneys from silent scarring?
NCT ID NCT04936282
First seen Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time
Summary
This trial tests whether giving a drug called Grafalon to kidney transplant recipients with early signs of rejection can prevent long-term kidney damage. About 80 low-risk patients will receive either Grafalon plus standard care or standard care alone. Researchers will measure kidney scarring and function after two years to see if the extra treatment helps preserve the transplanted organ.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Grafalon (anti-thymocyte globulin) given as a single-day infusion to treat early borderline lesions in kidney transplant recipients
- What this could lead to
- If effective, this approach could slow kidney scarring and preserve graft function, potentially extending the life of the transplanted kidney.
- What could go wrong
- This is a small, early-stage trial, and the treatment may not slow scarring or improve function. Grafalon can cause side effects like infusion reactions and increased infection risk.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2022
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients of either sex, older than 18 years, with no immunological risk (PRA\<20% and absence of DSA), who receive their first deceased donor or living donor KT. * Presence of BL, excluding isolated inflammation (t0, i\>0) and isolated tubulitis (t\>0, i0). * Patients receiving tacrolimus in combination with mycophenolic acid (MPA) and steroids. * Absence of clinical or subclinical and histological immunological dysfunction before randomization. * Absence of de novo DSA anti-HLA antibodies at the time of randomization. * Provision of written informed consent. * Acceptance of efficient contraception in women. Exclusion Criteria: * Recipients of a multi-organ transplant. * Re-transplants. * Patients without inflammation in the third month protocol biopsy (i0,t0), or with isolated inflammation without tubulitis (t0,i\>0) or isolated tubulitis without inflammation (t\>0,i0). * Presence of DSA antibodies before transplantation or at randomization. * Cold ischemia time \>30 hours. * Serum creatinine \>2.5 mg/dl or proteinuria \>1 g/day at randomization. * Presence of significant thrombopenia (\<100,000/mm3) or leukopenia (\<3000 mm/3) at randomization. * Previous episode of clinical or subclinical rejection (≥IA) before randomization. * CMV disease in the first three months after transplantation. * BK-polyomavirus nephropathy at randomization. * Recurrent or de novo glomerulonephritis. * Treatment with immunosuppressive drugs other than those in this clinical trial. * Patients who are positive for the human immunodeficiency virus (HIV) or with severe systemic infection, who, in the opinion of the investigator, require continued therapy. * Previous (within the last 5 years) or present malignancy, except excised basal or squamous cell carcinoma.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Fundación Puigvert
Barcelona, Barcelona, 08025, Spain
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Hospital Universitari Valld´Hebron
Barcelona, Barcelona, 08035, Spain
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Hospital Universitario de Canarias
Santa Cruz de Tenerife, None Selected, 38320, Spain
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Veronica Lopez Jimenez
Málaga, MALAGA, 29010, Spain
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