Humoral Rejection in Kidney TransplantationPhase 3RITUX-ERAHNCT01350882
Impact of Treatment With Rituximab on the Progression of Humoral Acute Rejection After Renal Transplantation
A Phase 3 study testing MabThera and Physiological serum : sodium chloride, sodium citrate in people with Humoral Rejection in Kidney Transplantation, run by University Hospital, Tours at 30 sites in France.
Trial summary
Assessing the impact of J12 curative treatment with rituximab (375 mg / m² on J5) based on a composite "TREATMENT FAILURE" Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Humoral Rejection in Kidney Transplantation
- What is being tested?
- MabThera and Physiological serum : sodium chloride, sodium citrate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 30 sitesFrance
- Study dates
- Oct 2008to Oct 2013
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient adult male or female (age 18 years), kidney transplantation for less than one year (transplant from a living donor or deceased), with acute humoral rejection defined by :
- The deterioration of renal function assessed by serum creatinine increase of more than 20% compared to the best value, OR
- In the first 28 days after transplantation, no significant creatinine decrease, AND
- At least 2 of the 3 following criteria:
- tissue damage such as (a) acute tubular necrosis, (b) presence of monocytes or granulocytes in the CPT and / or glomeruli and / or capillary thrombosis, (c) intimal arteritis / fibrinoid necrosis
- C4d level of CPT and / or presence of Ig or complement in lesions of fibrinoid necrosis
- Presence of HLA antibodies directed against the donor. Patient having given his written consent to participate in the clinical trial.
Who cannot join
- Pregnant or lactating
- Women during their reproductive years without effective contraception,
- A patient with multiple organ transplants,
- Patients with clinically active infection by HCV uncontrolled
- Patients with active infection, or suspected of infection by HIV or HBV, and tuberculosis,
- Patients with heart failure class IV (NYHA) cardiac disease or uncontrolled
Show all 12Show fewer
- Patients for whom vaccination is scheduled,
- Patient with disabilities did not allow an understanding of the requirements of the test
- Patient in safeguarding justice, guardianship or trusteeship,
- Patient with cons-indication to rituximab (known hypersensitivity to any component or murine protein)
- Patient had previously received rituximab within 3 months before inclusion
- Patient participation in another clinical trial
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
France30 sites
Hospital Sud
Amiens, 80054
Hospital
Angers, 49933
Hospital Saint-Jacques
Besançon, 25030
Hospital Pellegrin
Bordeaux, 33076
Hospital
Brest, 29609
Hospital
Caen, 14033
Hospital Gabriel Montpied
Clermont-Ferrand, 63003
Hospital Bocage
Dijon, 21000
Hospital
Grenoble, La Tronche, 38700
Hospital Calmette
Lille, 59037
Hospital Dupuytren
Limoges, 87042
Hospital Lyon Sud
Lyon, Pierre-Benite, 69495
Hospital Edouard Herriot
Lyon, 69437
Hospital Conception
Marseille, 13385
Hospital Lapeyronie
Montpellier, 34295
Hospital Hôtel Dieu
Nantes, 44093
Hospital Pasteur
Nice, 06000
Hospital Henri Mondor
Paris, Créteil, 94010
Hospital Bicêtre
Paris, Le Kremlin Bicêtre, 94275
Hospital Saint Louis
Paris, 75000
Hospital Tenon
Paris, 75020
Hospital Pitié-Salpêtrière
Paris, 75651
Hospital Necker
Paris, 75743
Hospital Milétrie Jean Bernard
Poitiers, 86021
Hospital Maison Blanche
Reims, 51092
Hospital
Rennes, 35033
Hospital Bois-Guillaume
Rouen, 76231
Hospital Nord
Saint-Etienne, Saint Priez-en-Jarez, 42227
Hospital Civil
Strasbourg, 67091
Hospital Bretonneau
Tours, 37044
About this study
Official title: Phase III Study of Impact of Treatment With Rituximab on the Progression of Humoral Acute Rejection After Renal Transplantation
Assessing the impact of J12 curative treatment with rituximab (375 mg / m² on J5) based on a composite "TREATMENT FAILURE"
- Being tested
- MabThera, Physiological serum : sodium chloride, sodium citrate
- Keywords
- kidney transplantation, acute humoral rejection, rituximab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MabTheraDrug
Also called rituximab
MabThera 500mg/50ml I.V. infusion, single dose : 375 mg/m2
Physiological serum : sodium chloride, sodium citrateDrug
Solution for I.V. infusion Sodium Chloride (pH 6.5), polysorbate 80, sodium citrate (10.0mg/ml)
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Patients randomized into the arm blind A. Rituximab is allowed as additional treatment from J12, within the limit of 2 infusions of rituximab. In case of insufficient efficacy of the treatment of acute humoral rejection, investigators may propose an additional infusion of rituximab from J12, without patient withdrawn. In this case (2nd infusion effective in group A and 1st infusion effective group B), a additional consultation (CS) will be provided as part of the study 7 days after infusion. In case of insufficient efficacy of the treatment,in fairness to care for patients between the 2 treatment groups, the investigators may propose to a 3rd infusion patients in group B (2nd infusion effective for this group). To prevent patients from group A will receive a 3rd infusion of rituximab, unblinding will be applied in this case by the investigator before the administration of additional treatment with rituximab. Receives: Drug: MabThera |
| B | Placebo comparator | Patients randomized into the arm blind B. Rituximab is allowed as additional treatment from J12, within the limit of 2 infusions of rituximab. In case of insufficient efficacy of the treatment of acute humoral rejection, investigators may propose an additional infusion of rituximab from J12, without patient withdrawn. In this case (2nd infusion effective in group A and 1st infusion effective group B), a additional consultation (CS) will be provided as part of the study 7 days after infusion. In case of insufficient efficacy of the treatment,in fairness to care for patients between the 2 treatment groups, the investigators may propose to a 3rd infusion patients in group B (2nd infusion effective for this group). To prevent patients from group A will receive a 3rd infusion of rituximab, unblinding will be applied in this case by the investigator before the administration of additional treatment with rituximab. Receives: Drug: Physiological serum : sodium chloride, sodium citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
"Treatment failure" grouping at J12: - Loss of graft - Whether improving renal function (defined by the absence of a decrease in creatinine of at least 30% compared to the maximum serum creatinine reached at the RAH)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2011 (estimated)
- Study startOct 2008
- Primary completionOct 2011
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Humoral Rejection in Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Responsible party
- Sponsor
- Investigators
- Yvon LEBRANCHU, Principal investigator, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01350882
- Sponsor's protocol ID
- PHRN07-YL RITUXERAH
- Acronym
- RITUX-ERAH
- Status last verified
- Jun 2026
- First submitted
- 4 Feb 2010
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Sautenet B, Blancho G, Buchler M, Morelon E, Toupance O, Barrou B, Ducloux D, Chatelet V, Moulin B, Freguin C, Hazzan M, Lang P, Legendre C, Merville P, Mourad G, Mousson C, Pouteil-Noble C, Purgus R, Rerolle JP, Sayegh J, Westeel PF, Zaoui P, Boivin H, Le Gouge A, Lebranchu Y. One-year Results of the Effects of Rituximab on Acute Antibody-Mediated Rejection in Renal Transplantation: RITUX ERAH, a Multicenter Double-blind Randomized Placebo-controlled Trial. Transplantation. 2016 Feb;100(2):391-9. doi: 10.1097/TP.0000000000000958.
PubMed 26555944
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of Impact of Treatment With Rituximab on the Progression of Humoral Acute Rejection After Renal Transplantation
- ClinicalTrials.gov ID
- NCT01350882
- Acronym / sponsor ID
- RITUX-ERAH / PHRN07-YL RITUXERAH
- Keywords
- kidney transplantation, acute humoral rejection, rituximab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- Oct 2008 (actual)
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 10 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assessing the impact of J12 curative treatment with rituximab (375 mg / m² on J5) based on a composite "TREATMENT FAILURE"
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: MabTheraPatients randomized into the arm blind A. Rituximab is allowed as additional treatment from J12, within the limit of 2 infusions of rituximab. In case of insufficient efficacy of the treatment of acute humoral rejection, investigators may propose an additional infusion of rituximab from J12, without patient withdrawn. In this case (2nd infusion effective in group A and 1st infusion effective group B), a additional consultation (CS) will be provided as part of the study 7 days after infusion. In case of insufficient efficacy of the treatment,in fairness to care for patients between the 2 treatment groups, the investigators may propose to a 3rd infusion patients in group B (2nd infusion effective for this group). To prevent patients from group A will receive a 3rd infusion of rituximab, unblinding will be applied in this case by the investigator before the administration of additional treatment with rituximab. |
| B | Placebo comparator | Drug: Physiological serum : sodium chloride, sodium citratePatients randomized into the arm blind B. Rituximab is allowed as additional treatment from J12, within the limit of 2 infusions of rituximab. In case of insufficient efficacy of the treatment of acute humoral rejection, investigators may propose an additional infusion of rituximab from J12, without patient withdrawn. In this case (2nd infusion effective in group A and 1st infusion effective group B), a additional consultation (CS) will be provided as part of the study 7 days after infusion. In case of insufficient efficacy of the treatment,in fairness to care for patients between the 2 treatment groups, the investigators may propose to a 3rd infusion patients in group B (2nd infusion effective for this group). To prevent patients from group A will receive a 3rd infusion of rituximab, unblinding will be applied in this case by the investigator before the administration of additional treatment with rituximab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient adult male or female (age 18 years), kidney transplantation for less than one year (transplant from a living donor or deceased), with acute humoral rejection defined by :
- The deterioration of renal function assessed by serum creatinine increase of more than 20% compared to the best value, OR
- In the first 28 days after transplantation, no significant creatinine decrease, AND
- At least 2 of the 3 following criteria:
Key exclusion criteria (12 listed)
- Pregnant or lactating
- Women during their reproductive years without effective contraception,
- A patient with multiple organ transplants,
- Patients with clinically active infection by HCV uncontrolled
- Patients with active infection, or suspected of infection by HIV or HBV, and tuberculosis,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MabTheraAlso: rituximabMabThera 500mg/50ml I.V. infusion, single dose : 375 mg/m2 | Drug | A |
| Physiological serum : sodium chloride, sodium citrateSolution for I.V. infusion Sodium Chloride (pH 6.5), polysorbate 80, sodium citrate (10.0mg/ml) | Drug | B |
Primary outcome
"Treatment failure" grouping at J12: - Loss of graft - Whether improving renal function (defined by the absence of a decrease in creatinine of at least 30% compared to the maximum serum creatinine reached at the RAH)
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Results publication: PubMed 26555944Sautenet B, Blancho G, Buchler M, Morelon E, Toupance O, Barrou B, Ducloux D, Chatelet V, Moulin B, Freguin C, Hazzan M, Lang P, Legendre C, Merville P, Mourad G, Mousson C, Pouteil-Noble C, Purgus R, Rerolle JP, Sayegh J, Westeel PF, Zaoui P, Boivin H, Le Gouge A, Lebranchu Y. One-year Results of the Effects of Rituximab on Acute Antibody-Mediated Rejection in Renal Transplantation: RITUX ERAH, a Multicenter Double-blind Randomized Placebo-controlled Trial. Transplantation. 2016 Feb;100(2):391-9. doi: 10.1097/TP.0000000000000958.
Related trials for Humoral Rejection in Kidney Transplantation
Not yet recruitingObservational study
Study of Alloimmune Response in Humoral Rejection After Kidney Transplantation
Kidney Transplantation, Kidney Allograft Biopsy
Not yet recruitingObservational study
Study of the Pathogenicity and Humoral Immune Response Induced by BK Virus in Lung Transplant Recipients
Renal-urinary Impairment, Graft Rejection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yvon LEBRANCHU principal investigator
University Hospital, Tours
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MabThera and Physiological serum : sodium chloride, sodium citrate in people with Humoral Rejection in Kidney Transplantation, run by University Hospital, Tours at 30 sites 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 7 inclusion and 12 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 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
"Treatment failure" grouping at J12: - Loss of graft - Whether improving renal function (defined by the absence of a decrease in creatinine of at least 30% compared to the maximum serum creatinine reached at the RAH) (time frame: one year). 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 NCT01350882, 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 12 Jun 2026.