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Simulect Versus ATG in Sensitized Renal Transplant Patient

CompletedPhase 4

Sponsor: University Hospital, Toulouse

Conditions: Renal Transplant Rejection

Interventions: Simulect, ATG Fresenius

Countries: France

Induction therapy by either T-cell depleting polyclonal antibodies such as anti-thymocyte globulins (ATG) or non-depleting anti-interleukine 2 receptor monoclonal antibodies (anti-CD25 moAb: basiliximab or daclizumab) are used to prevent acute rejection, especially in highly sensitized patients. Both induction therapy regimens have a different tolerance profile. Infections and haematological side-effects are more frequently reported in patients receiving ATG. The aim of the pilot study is to evaluate ATG and basiliximab induction therapy in de novo sensitized kidney-transplant patients (incompatible grafts rate ≥ 50%) without donor specific antibodies (DSAs) detected by Luminex.

Eligibility overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Male or female patients aged from 18 to 70 years
* Recipient of a deceased or living donor kidney transplant with the following criteria:
* Incompatible grafts rate ≥ 50% for the last available serum before transplantation \< 3 months
* Anti-HLA antibodies positive
* Negative DSA by luminex method on historical serum and day serum
* T and B negative Cross match on historical and day serum
* Females capable of becoming pregnant must have a negative serum pregnancy test within 7 days prior to or at screening, and are required to practice an approved and reliable method of birth control for the duration of the study and for a period of 2 months after study medication discontinuation, even where there has been a history of infertility
* Patients who are willing and able to participate in the full course of the study and from whom written informed consent has been obtained.
* Patients affiliated to, or recipients of, a social security system

Exclusion Criteria:

* Recipients of a multi-organ transplantation, including dual kidneys, or who have previously received non renal transplanted organs
* Recipients of a kidney from non-heart beating donor, or with ABO incompatibility against the donor or with a T positive cross match
* Patients with severe uncontrolled systemic infection or severe allergy requiring acute or chronic treatment
* Aspartate aminotransferase (ASAT), Alanine Amino Transferase (ALAT) or bilirubin ≥ 3 upper limit of the normal range (ULN)
* Known hypersensitivity or contra-indication to rabbit proteins, basiliximab, tacrolimus, mycophenolic acid or any of the product excipients
* Patients who are Hepatitis C positive (positive PCR and normal hepatic test may be included), HIV positive, or Hepatitis B surface antigen positive (AgHBs).
* Patients with thrombocytopenia \< 75,000/mm3, an absolute neutrophils count \< 1,500/mm3, leukocytopenia \< 2,500/mm3, and/or hemoglobin \< 8g/dL at inclusion visit
* Patients with any past or present malignancy within the last five years except excised squamous or basal cell carcinoma of the skin and treated in situ cervix uteri cancer
* Any surgical or medical condition, excluding transplantation which compromise the inclusion of the patient (investigator's opinion)
* Female patients who are pregnant, breast feeding or capable to become pregnant and not wishing or capable to practice a medically approved and reliable method of birth control
* Patients with symptoms of significant somatic or mental illness. Inability to cooperate or communicate with the investigator

Locations (1)

Toulouse, France, France