Authorised Therapeutic exploratory (Phase II) renal transplant

ODORAT : Optimal dose of anti-lymphocyte globulin in kidney transplant recipients with low immunological risk

EU CTIS ID: 2024-514792-17-00

What this study is testing

The purpose of this study is to find the optimal non-depleting dose (MTD) of rabbit anti-human T-lymphocyte immunoglobulin (Grafalon®) to prevent the complications associated with prolonged CD4 T cell lymphopenia in low immunological risk renal transplant recipients.

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Age ≥ 18 years
  • Patient receiving first kidney transplantation

You likely can't join if

  • History of opportunistic infection that required intensive care hospitalization in the two years preceding the transplant
  • Anti-HLA immunization (Flow PRA > or = 20%, presence of donor specific antibody before and/or at time of transplantation and with a positive CDC and FXM with historical and/or transplant day sera)
  • Multi-organ transplant
  • Previous transplant(s)
  • History of cancer
  • Thrombocytopenia < 50 000 platelets
See the full eligibility criteria
Who can join
  • Age ≥ 18 years
  • Patient receiving first kidney transplantation
What rules you out
  • History of opportunistic infection that required intensive care hospitalization in the two years preceding the transplant
  • Anti-HLA immunization (Flow PRA > or = 20%, presence of donor specific antibody before and/or at time of transplantation and with a positive CDC and FXM with historical and/or transplant day sera)
  • Multi-organ transplant
  • Previous transplant(s)
  • History of cancer
  • Thrombocytopenia < 50 000 platelets
  • Any active infections or Infection with Hepatitis C, B viruses or HIV
  • Pregnant or breast-feeding subjects,

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.