Function of Renal TransplantPhase 4ReMINDNCT01095172
RituxiMab INDuction in Renal Transplantation
A Phase 4 study testing Rituximab, Tacrolimus and Mycophenylate mofetil in people with Function of Renal Transplant, run by Guy's and St Thomas' NHS Foundation Trust at 6 sites in United Kingdom.
Trial summary
Hypothesis: That B cell depletion, rather than reducing acute rejection, will allow minimisation of immunosuppression, which may lead to better graft survival. Aim: To assess whether the addition of rituximab to a low-dose tacrolimus immunosuppression regime allows a reduction in steroid administration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Function of Renal Transplant
- What is being tested?
- Rituximab, Tacrolimus and Mycophenylate mofetil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 6 sitesUnited Kingdom
- Study dates
- Nov 2010to Oct 2022
- Phase
- Phase 4
- 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
- Adult patients over 18 years receiving their first living donor renal transplant, or their second if the first was not lost from acute rejection
- Patients who have given written informed consent
- Women of child bearing potential taking adequate contraception.
Who cannot join
- Previous other organ transplants lost through acute rejection
- Patients undergoing antibody incompatible transplantation
- Patients with other organ transplants
- Patients previously treated with cyclophosphamide, ATG, OKT3 or rituximab
- Patients with white cell count below 4.0x10^9/L.
- Patients with platelet count below 100x10^9/L
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- Patients who are treated with drugs that are strong inhibitors or inducers of cytochrome P450, or treated with terfenadine, astemizole, cisapride or lovastatin
- Patients who have been involved in any other investigational trial or non protocol immunosuppressive regimen in the previous 90 days prior to transplant
- Pregnant or breastfeeding women
- Patients with a documented history of malignancy and its origins and treatment in the last five years. (Localised basal cell carcinoma of the skin is permitted)
- Patients known to be HIV, Hepatitis B surface antigen or Hepatitis C antibody positive
- Patients who in the opinion of the Investigator would not be a suitable candidate for study participation
- Women of child bearing potential not willing to take adequate contraception
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United Kingdom6 sites
East Kent Hospitals NHS Foundation Trust
Canterbury, Kent, CT1 3NG
Glasgow Renal and Transplant Unit
Glasgow, G11 6NT
Guy's and St Thomas' NHS Foundation Trust
London, SE1 9RT
Central Manchester University Hospitals NHS Foundation Trust
Manchester, M13 9WL
South West Transplant Centre
Plymouth, Devon, PL6 8DH
Sheffield Kidney Institute
Sheffield, S5 7AU
About this study
Official title: A Randomized Trial of Rituximab in Induction Therapy for Living Donor Renal Transplantation
Hypothesis:
- That B cell depletion, rather than reducing acute rejection, will allow minimisation of immunosuppression, which may lead to better graft survival.
Aim:
- To assess whether the addition of rituximab to a low-dose tacrolimus immunosuppression regime allows a reduction in steroid administration.
Objectives:
- To assess whether B cell depletion affects graft function, acute rejection and complication rates
- To assess whether the T cell response to allotransplantation is impaired by B cell depletion.
- Conditions
- Function of Renal Transplant
- Being tested
- Rituximab, Tacrolimus, Mycophenylate mofetil, Hydrocortisone, Prednisolone
- Keywords
- Immunosuppression, Rituximab, B cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Also called Mabthera
375mg/m^2, single dose given 2-4 weeks prior to transplantation
TacrolimusDrug
Also called Advagraf, Adoport, Prograf
dose calculated to give levels of 3-7ng/ml
Mycophenylate mofetilDrug
Also called MMF, Cellcept
Mycophenylate mofetil 2g/day in divided doses
HydrocortisoneDrug
100mg hydrocortisone on the evening of the day of surgery and 2 further doses of hydrocortisone on day 1 post transplant.
PrednisoloneDrug
Prednisolone 0.3mg/kg on day 2, 0.25mg/kg on day 3, 0.2mg/kg on day 4 and 0.16mg/kg on day 5. On day 6 they will receive 5mg prednisolone, and on day 7 none.
PrednisoloneDrug
Reducing dose of prednisolone over at least 6 months. Subsequent steroid maintenance or withdrawal will be at the discretion of the patient's clinician.
| Study group | Role | What they receive |
|---|---|---|
| Rituximab | Experimental | Rituximab 375mg/m2
Low dose tacrolimus with mycophenylate mofetil, hydrocortisone and 1 week prednisolone Receives: Drug: Rituximab; Drug: Tacrolimus; Drug: Mycophenylate mofetil; Drug: Hydrocortisone; Drug: Prednisolone |
| Control group | Active comparator | Low dose tacrolimus with mycophenylate mofetil and continued prednisolone Receives: Drug: Tacrolimus; Drug: Mycophenylate mofetil; Drug: Hydrocortisone; Drug: Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated GFR (calculated using the Cockcroft-Gault formula)
Measured: 1 year
Secondary outcomes (5)
Biopsy proven acute rejection (based on Banff classification)
Measured: 1, 2, 3, 4, 5 years
Allograft survival
Measured: 1, 2, 3, 4, 5 years
Patient Survival
Measured: 1, 2, 3, 4, 5 years
Infection rate
New episodes, including (but not restricted to) viral (e.g. CMV, EBV), bacterial (e.g. Urinary Tract Infections with details of causative organism) and fungal infections will be recorded at each assessment time-point.
Measured: 1 year
Changes in B and T cell repertoire
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2010 (estimated)
- Study startNov 2010
- Primary completionOct 2020 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Function of Renal TransplantStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Europe Ltd.
- Responsible party
- Principal investigator, Nizam Mamode, Guy's and St Thomas' NHS Foundation Trust
- Investigators
- Nizam Mamode, MD FRCS(Gen), Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01095172
- Sponsor's protocol ID
- RituxiRT
- Other IDs
- 2009-017066-23, 95769119, 9154, 2009
- Acronym
- ReMIND
- Status last verified
- Jul 2020
- First submitted
- 26 Mar 2010
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Rituximab in Induction Therapy for Living Donor Renal Transplantation
- ClinicalTrials.gov ID
- NCT01095172
- Acronym / sponsor ID
- ReMIND / RituxiRT
- Conditions
- Function of Renal Transplant
- Keywords
- Immunosuppression, Rituximab, B cell
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Astellas Pharma Europe Ltd.
- Study start
- Nov 2010
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 30 Mar 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.
Hypothesis:
- That B cell depletion, rather than reducing acute rejection, will allow minimisation of immunosuppression, which may lead to better graft survival.
Aim:
- To assess whether the addition of rituximab to a low-dose tacrolimus immunosuppression regime allows a reduction in steroid administration.
Objectives:
- To assess whether B cell depletion affects graft function, acute rejection and complication rates
- To assess whether the T cell response to allotransplantation is impaired by B cell depletion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rituximab | Experimental | Drug: Rituximab, Drug: Tacrolimus, Drug: Mycophenylate mofetil, Drug: Hydrocortisone, Drug: PrednisoloneRituximab 375mg/m2 Low dose tacrolimus with mycophenylate mofetil, hydrocortisone and 1 week prednisolone |
| Control group | Active comparator | Drug: Tacrolimus, Drug: Mycophenylate mofetil, Drug: Hydrocortisone, Drug: PrednisoloneLow dose tacrolimus with mycophenylate mofetil and continued prednisolone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients over 18 years receiving their first living donor renal transplant, or their second if the first was not lost from acute rejection
- Patients who have given written informed consent
- Women of child bearing potential taking adequate contraception.
Key exclusion criteria (13 listed)
- Previous other organ transplants lost through acute rejection
- Patients undergoing antibody incompatible transplantation
- Patients with other organ transplants
- Patients previously treated with cyclophosphamide, ATG, OKT3 or rituximab
- Patients with white cell count below 4.0x10^9/L.
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 |
|---|---|---|
| RituximabAlso: Mabthera375mg/m^2, single dose given 2-4 weeks prior to transplantation | Drug | Rituximab |
| TacrolimusAlso: Advagraf, Adoport, Prografdose calculated to give levels of 3-7ng/ml | Drug | Control group, Rituximab |
| Mycophenylate mofetilAlso: MMF, CellceptMycophenylate mofetil 2g/day in divided doses | Drug | Control group, Rituximab |
| Hydrocortisone100mg hydrocortisone on the evening of the day of surgery and 2 further doses of hydrocortisone on day 1 post transplant. | Drug | Control group, Rituximab |
| PrednisolonePrednisolone 0.3mg/kg on day 2, 0.25mg/kg on day 3, 0.2mg/kg on day 4 and 0.16mg/kg on day 5. On day 6 they will receive 5mg prednisolone, and on day 7 none. | Drug | Rituximab |
| PrednisoloneReducing dose of prednisolone over at least 6 months. Subsequent steroid maintenance or withdrawal will be at the discretion of the patient's clinician. | Drug | Control group |
Primary outcome
Estimated GFR (calculated using the Cockcroft-Gault formula)
Time frame: 1 year
5 secondary outcomes
Biopsy proven acute rejection (based on Banff classification)
Time frame: 1, 2, 3, 4, 5 years
Allograft survival
Time frame: 1, 2, 3, 4, 5 years
Patient Survival
Time frame: 1, 2, 3, 4, 5 years
Infection rate
Time frame: 1 year
Changes in B and T cell repertoire
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
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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.
Nizam Mamode, MD FRCS(Gen) principal investigator
Guy's and St Thomas' NHS Foundation Trust
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rituximab, Tacrolimus and Mycophenylate mofetil in people with Function of Renal Transplant, run by Guy's and St Thomas' NHS Foundation Trust at 6 sites in United Kingdom.
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 3 inclusion and 13 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 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
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?
Estimated GFR (calculated using the Cockcroft-Gault formula) (time frame: 1 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 22 Jul 2020.