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New drug cocktail could spare kidney transplant patients from lifelong steroids

NCT ID NCT02711202

Disease control Sponsor: Institute for Clinical and Experimental Medicine Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study tested a new combination of two drugs, Alemtuzumab and Infliximab, given right after a kidney transplant to prevent rejection. The goal was to see if patients could avoid long-term steroids and calcineurin inhibitors. Twenty first-time kidney transplant recipients were enrolled and followed for one year to check survival, graft function, and rejection rates.

What this could mean

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

Active substance
Alemtuzumab and Infliximab
What this could lead to
If successful, this approach could reduce the need for long-term steroids and calcineurin inhibitors after kidney transplant, potentially lowering side effects.
What could go wrong
This is a very small pilot study with only 20 patients, so results may not apply to everyone. The new regimen may not prevent rejection as well as standard care.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

20 people

The number who actually took part.

Start date

Jan 2007

Finished

Mar 2009

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

18 years and older

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: * First deceased-donor kidney transplantation * Age \>18 years * Donor \<65 years * Cytomegalovirus (CMV)/ Epstein-Barr virus (EBV) seropositivity * panel reactive antibodies (PRA) \<10% * Written consent Exclusion criteria: * Retransplantation, combined transplantation * Prior immunosuppression less than 6 months prior transplantation * Induction therapy with antibodies * Leukopenia \< 4000, thrombocytopenia \< 100 000, Haemoglobin \< 80 g/l * History of antithymoglobulin (ATG) or anti-cluster of differentiation 3 (CD3) monoclonals or anti-TNF-α * Tuberculosis history * Anti-hepatitis C virus (HCV) positivity, HBsAg * HIV positivity * Malignancy history * Allergy to study medication * Fertile women without contraception * Pregnancy, breastfeeding mothers

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As listed by the trial registrant

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

Kidney transplantation

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