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New drug cocktail aims to stop kidney rejection in transplant patients

NCT ID NCT02201576

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tested whether a drug called bortezomib, given with steroids, plasma exchange, and immunoglobulins, can treat chronic antibody-mediated rejection in kidney transplant recipients. The trial included 60 adults who had a kidney transplant and developed donor-specific antibodies. The goal was to see if this combination could reduce signs of rejection in kidney tissue and lower harmful antibody levels.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

60 people

The number who actually took part.

Started

Feb 2015

Finished

Jul 2020

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 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: * recipients of a first or a second kidney transplant for more than 3 months * age over 18 years * with de novo donor specific antibodies (DSA), i.e. antibodies not detected the day of transplantation and in pre-transplant sera * with histological lesions of chronic active antibody-mediated rejection (glomerulitis + peritubular capillaritis banff score and chronic glomerulopathy (g+ptc ≥ 2) on a graft biopsy performed because of renal function deterioration, proteinuria, detection of de novo DSA, or on a systematic biopsy * written informed consent * Given the teratogenic risks described in the SPCs of Velcade and Cellcept: * Women of child bearing age must have a negative pregnancy test the day of the inclusion and should use at least one effective contraceptive method before start of medication during the treatment and during the study * Men old enough to procreate have to use condoms during the treatment and at least 90 days after the last intake of the treatment during the study. Moreover, given SPCs of Cellcept, it is recommended that female partners to use an effective method of contraception treatment and for 90 days after the last mycophenolate intake by the partner male * affiliated with social security health insurance * patients with cell rejection lesions associated with chronic humoral rejection lesions active may be included in the study. This rejection can be treated with 3 boluses of 500 mg of methyl prednisolone prior to inclusion. Exclusion Criteria: * patient with preformed DSA * recipient of a 3rd or 4th kidney transplant * recipient of a transplant combined with another not renal organ * patient with a history of humoral acute rejection during the current transplantation * estimated GFR below 20 ml/min/1,73m2 * severe transplant glomerulopathy (cg score = 3) * severe peripheral neuropathy, thrombopenia \< 100 000 mm3 , neutropenia \< 1000 mm3 and/or an uncontrolled evolutionary infection * chronic active hepatitis B (positive HBs antigen or HBV DNA), positive chronic hepatitis C and/or known HIV infection * allergy to bore or bortezomib or to one of the excipient * hepatic failure, abnormal liver tests (bilirubin \>3N, transaminases \>3n), infiltrative pneumopathy, pericarditis * risk of non-adherence to treatment or protocol * inclusion in another clinical therapeutic trial

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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

  • Hopital Necker Enfants-malades

    Paris, 75015, France