Graft RejectionPhase 3RITUX-ERAHNCT01066689
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 Graft Rejection, run by University Hospital, Tours at 32 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
- Graft Rejection
- 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
- 64 participants
- Where
- 32 sitesFrance
- Study dates
- Oct 2008to Oct 2011
- 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
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- 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
32 sites in 1 country.
32 sites in 1 country
France32 sites, 17 recruiting
- Recruiting
Hospital Sud
Amiens, 80054
Pierre-François WESTEEL
- Active, not recruiting
Hospital
Angers, 49933
- Recruiting
Hospital Saint-Jacques
Besançon, 25030
Didier DUCLOUX
- Recruiting
Hospital Pellegrin
Bordeaux, 33076
Pierre MERVILLE
- Active, not recruiting
Hospital
Brest, 29609
- Recruiting
Hospital
Caen, 14033
Bruno HURAULT DE LIGNY
- Active, not recruiting
Hospital Gabriel Montpied
Clermont-Ferrand, 63003
- Active, not recruiting
Hospital Bocage
Dijon, 21000
- Active, not recruiting
Hospital
Grenoble, La Tronche, 38700
- Recruiting
Hospital Calmette
Lille, 59037
Marc HAZZAN
- Recruiting
Hospital Dupuytren
Limoges, 87042
Jean-Philippe REROLLE
- Recruiting
Hospital Lyon Sud
Lyon, Pierre-Benite, 69495
Claire POUTEIL-NOBLE
- Recruiting
Hospital Edouard Herriot
Lyon, 69437
Emmanuel MORELON
- Active, not recruiting
Hospital Conception
Marseille, 13385
- Recruiting
Hospital Lapeyronie
Montpellier, 34295
Georges MOURAD
- Withdrawn
Hospital Nancy-Brabois
Nancy, Vandoeuvre-les-Nancy, 54511
- Recruiting
Hospital Hôtel Dieu
Nantes, 44093
Gilles BLANCHO
- Active, not recruiting
Hospital Pasteur
Nice, 06000
- Recruiting
Hospital Henri Mondor
Paris, Créteil, 94010
Philippe LANG
- Active, not recruiting
Hospital Bicêtre
Paris, Le Kremlin Bicêtre, 94275
- Withdrawn
Hospital Foch
Paris, Suresnes, 92151
- Not yet recruiting
Hospital Saint Louis
Paris, 75000
Denis GLOTZ
- Active, not recruiting
Hospital Tenon
Paris, 75020
- Recruiting
Hospital Pitié-Salpêtrière
Paris, 75651
Benoît BARROU
- Recruiting
Hospital Necker
Paris, 75743
Eric THERVET
- Active, not recruiting
Hospital Milétrie Jean Bernard
Poitiers, 86021
- Recruiting
Hospital Maison Blanche
Reims, 51092
Olivier TOUPANCE
- Active, not recruiting
Hospital
Rennes, 35033
- Recruiting
Hospital Bois-Guillaume
Rouen, 76231
Stéphane BARBIER
- Active, not recruiting
Hospital Nord
Saint-Etienne, Saint Priez-en-Jarez, 42227
- Active, not recruiting
Hospital Civil
Strasbourg, 67091
- Recruiting
Hospital Bretonneau
Tours, 37044
Yvon LEBRANCHU
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"
- Conditions
- Graft Rejection
- 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 citrate)Drug
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 Feb 2010 (estimated)
- Study startOct 2008
- Primary completionOct 2011 (estimated)
- Study completionOct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft RejectionStudies 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
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Investigators
- Yvon LEBRANCHU, Principal investigator, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01066689
- Sponsor's protocol ID
- PHRN07-YL RITUX-ERAH
- Acronym
- RITUX-ERAH
- Status last verified
- Feb 2010
- First submitted
- 3 Feb 2010
- Last updated
- 10 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2010. 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
- NCT01066689
- Acronym / sponsor ID
- RITUX-ERAH / PHRN07-YL RITUX-ERAH
- Conditions
- Graft Rejection
- Keywords
- kidney transplantation, acute humoral rejection, rituximab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- Oct 2008
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Oct 2011 (estimated)
- First posted
- 10 Feb 2010 (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 citrate)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. |
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 citrate)Solution 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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2010.
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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
32 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 Graft Rejection, run by University Hospital, Tours at 32 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: status not confirmed, as of the sponsor's last update on 10 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yvon LEBRANCHU (02.47.47.82.29, lebranchu@med.univ-tours.fr), or a site near the patient. 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?
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 10 Feb 2010.