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Renal Transplant RejectionPhase 4SATIRNCT02377193

Simulect Versus ATG in Sensitized Renal Transplant Patient

A Phase 4 study testing Simulect and ATG Fresenius in people with Renal Transplant Rejection, run by University Hospital, Toulouse at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Renal Transplant Rejection
What is being tested?
Simulect and ATG Fresenius
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteFrance
Study dates
Sep 2013to Jan 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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).
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  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • UHToulouse

    Toulouse, France, 31059

Other trials in France

About this study

Official title: Prospective, Multicenter, Randomized, Evaluating Two Induction Therapies With Simulect® Versus ATG® Fresenius Associated With Tacrolimus and Myfortic® in the Prevention of Treatment Failure, in Sensitized Renal Transplant

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.

Read the detailed description

Acute rejection after kidney transplantation can lead to graft loss by irreversible acute rejection or to interstitial fibrosis/ tubular atrophy that can induce graft loss. 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. With respect to the efficacy, no comparison exists between both induction therapy regimens in high risk immunological patients as actually defined. Within the last few years, the development of new immunological screening tools, i.e. Luminex assay, had lead to a better evaluation of the immunological status of candidates for kidney transplantation, mainly those who were considered as highly sensitized. The aim of our 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. Maintenance immunosuppressive regimen will be based on the combination of tacrolimus, mycophenolate sodium and steroids. The primary endpoint is a composite of biopsy-proven acute rejection, graft loss, loss of follow up, or death at 6 months post-transplant. The secondary endpoints are the efficacy of the therapy at month 12 posttransplant, and safety parameters (CMV infection, BK virus nephropathy, haematological tolerance, Adverse Events (AE)and Serious Adverse Events (SAE)). Our hypothesis is that basiliximab induction therapy may be sufficiently effective to prevent acute rejection in sensitized patients without DSA. This may reduce the post-transplant immunosuppression-induced side-effects.

Being tested
Simulect, ATG Fresenius
Keywords
kidney transplant, luminex method, simulect ATG, immunosuppression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SimulectDrug

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

    Simulect IV 40 mg/day D0 and D4

    and oral use Tacrolimus 0.1 mg/ kg/ day + Myfortic 720 to 1440mg + Corticosteroids 5mg

  • ATG FreseniusDrug

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

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

Study groups in NCT02377193
Study groupRoleWhat they receive
SimulectExperimentalSimulect IV 40 mg D0 and D4
Receives: Drug: Simulect
ATG FreseniusActive comparatorATG IV min dose 3 mg/ kg/ day D0, D1, D3, D5
Receives: Drug: ATG Fresenius

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months

Secondary outcomes (12)

  1. feasibility estimating the number of informed consent obtained

    Estimating the number of informed consent obtained

    Measured: 12 months

  2. treatment efficacy

    Treatment failure at 12 months post transplantation.

    • premature discontinuation of study medication, discontinuation from the study and reasons.
    • incidence of all acute rejection episodes requiring an anti-T and /or anti-B antibodies treatment within 12 months post transplantation.
    • Incidence of C4d positive biopsy findings.
    • Renal function at 3, 6 and 12 months post transplantation (abbreviated MDRD, serum creatinine and adjusted Cockcroft- Gault).

    Measured: 12 months

  3. adverse events

    Safety:

    • Adverse Events, Serious Adverse Events

    Measured: 12 months

  4. patient enrolled in each center

    Estimating the number of patient enrolled in each center and by year

    Measured: 12 months

  5. number of patients lost from follow-up

    Estimating the number of patients lost from from follow-up before 6 and before 12 months

    Measured: 12 months

  6. rejection

    acute rejection at 6 and 12 months post transplantation

    • Subclinical rejection at the 3 month per protocol renal biopsy.

    Measured: 12 months

  7. Donor Specific Antibodies

    Donor Specific Antibodies at D0, M3 and M12.

    Measured: 12 months

  8. Incidence of BKV viremia

    incidence of BKV viremia at 1, 3, 6 and 12 months post transplantation

    Measured: 12 months

  9. values of hematologia : hemoglobine, leucocytes, plaquettes, hematies, neutrophiles

    Measured: 12 months

  10. Incidence of BKV nephropathy

    Incidence of BKV nephropathy at 1, 3, 6 and 12 months post transplantation

    Measured: 12 months

  11. incidence of CMV post transplantation

    incidence of CMV(PCR) post transplantation at 6, 9 and 12 months

    Measured: 12 months

  12. incidence of infections

    incidence of infections cancer and PTLD

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2015 (estimated)
  2. Study startSep 2013
  3. Primary completionJan 2017
  4. Study completionJan 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02377193
Sponsor's protocol ID
12 484 03
Acronym
SATIR
Status last verified
Oct 2017
First submitted
11 Jun 2014
Last updated
8 Apr 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 32775820

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Simulect and ATG Fresenius in people with Renal Transplant Rejection, run by University Hospital, Toulouse at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment failure (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02377193, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.

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