Simulect Versus ATG in Sensitized Renal Transplant Patient

NCT02377193 | Completed Phase 4 DMC

• 1 other identifier: 12 484 03
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Renal Transplant Rejection

Keywords

kidney transplant; luminex method; simulect ATG; immunosuppression

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment failure

  Incidence of treatment failure (Biopsy Proved Reject, lost to follow up, graft loss or death) at 6 months post transplantation.

  6 months

Secondary Outcomes (12)

• feasibility estimating the number of informed consent obtained

  12 months

• treatment efficacy

  12 months

• adverse events

  12 months

• patient enrolled in each center

  12 months

• number of patients lost from follow-up

  12 months

Study Arms (2)

Simulect

EXPERIMENTAL

Simulect IV 40 mg D0 and D4

Drug: Simulect

ATG Fresenius

ACTIVE COMPARATOR

ATG IV min dose 3 mg/ kg/ day D0, D1, D3, D5

Drug: ATG Fresenius

Interventions

Simulect DRUG

Simulect IV 40 mg/day D0 and D4 and oral use Tacrolimus 0.1 mg/ kg/ day + Myfortic 720 to 1440mg + Corticosteroids 5mg

Also known as: Simulect IV 40 mg/day D0 and D4, and oral use Tacrolimus 0.1 mg/ kg/ day +, Myfortic 720 to 1440mg +, Corticosteroids 5mg

Simulect

ATG Fresenius DRUG

Simulect IV 40 mg/day D0 and D4 and oral use Tacrolimus 0.1 mg/ kg/ day + Myfortic 720 to 1440mg + Corticosteroids 5mg

Also known as: Simulect IV 40 mg/day D0 and D4, and oral use Tacrolimus 0.1 mg/ kg/ day +, Myfortic 720 to 1440mg +, Corticosteroids 5mg

ATG Fresenius

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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
• 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

Sponsors & Collaborators

• Neovii Biotech: collaborator
• Novartis: collaborator
• University Hospital, Toulouse: lead

Study Sites (1)

UHToulouse

Toulouse, France, 31059, France

Location

Related Publications (1)

• Kamar N, Lepage B, Couzi L, Albano L, Durrbach A, Pernin V, Esposito L, Hebral AL, Darres A, Lequintrec M, Cassuto E, Merville P, Congy N, Del Bello A. A Randomized Prospective Study Comparing Anti-T-Lymphocyte Igs to Basiliximab in Highly Sensitized Kidney Transplant Patients. Kidney Int Rep. 2020 Jun 2;5(8):1207-1217. doi: 10.1016/j.ekir.2020.05.020. eCollection 2020 Aug.

  PMID: 32775820 RESULT

MeSH Terms

Interventions

Basiliximab; Adrenal Cortex Hormones

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Nassim Kamar, MD PhD

  University Hospital, Toulouse

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2014
• First Posted: March 3, 2015
• Study Start: September 1, 2013
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: April 8, 2026

Record last verified: 2017-10

Locations

FR (1)