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Kidney transplant study: which drug better prevents rejection?

NCT ID NCT02377193

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested two different drug combinations (Simulect or ATG, plus standard medications) in 60 kidney transplant patients at high risk of rejection. The goal was to see which approach better prevents treatment failure, including rejection, graft loss, or death, within 6 months. Results could help tailor therapy for sensitized patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Simulect (basiliximab) and ATG Fresenius (anti-thymocyte globulin)
What this could lead to
If successful, this could help doctors choose the safer and more effective induction therapy for sensitized kidney transplant patients, reducing rejection risk.
What could go wrong
This is a small pilot study with only 60 participants, so results may not apply to all patients. Both drugs have side effects, including infection risk.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

60 people

The number who actually took part.

Start date

Sep 2013

Finished

Jan 2017

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • UHToulouse

    Toulouse, France, 31059, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.