New drug cocktail aims to stop kidney rejection in transplant patients
NCT ID NCT02201576
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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60 people
The number who actually took part.
- Started
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Feb 2015
- Finished
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Jul 2020
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Hopital Necker Enfants-malades
Paris, 75015, France