Simulect Versus ATG in Sensitized Renal Transplant Patient

• Status: Completed
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Toulouse
• Collaborators: Neovii Biotech; Novartis
• Treatments: Antibodies, Monoclonal; Basiliximab; Mycophenolate mofetil; Mycophenolic Acid; Tacrolimus

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