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RituxiMab INDuction in Renal Transplantation (ReMIND)

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ClinicalTrials.gov Identifier: NCT01095172
Recruitment Status : Active, not recruiting
First Posted : March 30, 2010
Last Update Posted : April 1, 2019
Sponsor:
Collaborator:
Astellas Pharma Europe Ltd.
Information provided by (Responsible Party):
Nizam Mamode, Guy's and St Thomas' NHS Foundation Trust

Brief 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.

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.

Condition or disease Intervention/treatment Phase
Function of Renal Transplant Drug: Rituximab Drug: Tacrolimus Drug: Mycophenylate mofetil Drug: Hydrocortisone Drug: Prednisolone Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial of Rituximab in Induction Therapy for Living Donor Renal Transplantation
Study Start Date : November 2010
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Rituximab

Arm Intervention/treatment
Experimental: Rituximab

Rituximab 375mg/m2

Low dose tacrolimus with mycophenylate mofetil, hydrocortisone and 1 week prednisolone

Drug: Rituximab
375mg/m^2, single dose given 2-4 weeks prior to transplantation
Other Name: Mabthera

Drug: Tacrolimus
dose calculated to give levels of 3-7ng/ml
Other Name: Advagraf, Adoport, Prograf

Drug: Mycophenylate mofetil
Mycophenylate mofetil 2g/day in divided doses
Other Name: MMF, Cellcept

Drug: Hydrocortisone
100mg hydrocortisone on the evening of the day of surgery and 2 further doses of hydrocortisone on day 1 post transplant.

Drug: Prednisolone
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.

Active Comparator: Control group
Low dose tacrolimus with mycophenylate mofetil and continued prednisolone
Drug: Tacrolimus
dose calculated to give levels of 3-7ng/ml
Other Name: Advagraf, Adoport, Prograf

Drug: Mycophenylate mofetil
Mycophenylate mofetil 2g/day in divided doses
Other Name: MMF, Cellcept

Drug: Hydrocortisone
100mg hydrocortisone on the evening of the day of surgery and 2 further doses of hydrocortisone on day 1 post transplant.

Drug: Prednisolone
Reducing dose of prednisolone over at least 6 months. Subsequent steroid maintenance or withdrawal will be at the discretion of the patient's clinician.




Primary Outcome Measures :
  1. Estimated GFR (calculated using the Cockcroft-Gault formula) [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Biopsy proven acute rejection (based on Banff classification) [ Time Frame: 1, 2, 3, 4, 5 years ]
  2. Allograft survival [ Time Frame: 1, 2, 3, 4, 5 years ]
  3. Patient Survival [ Time Frame: 1, 2, 3, 4, 5 years ]
  4. Infection rate [ Time Frame: 1 year ]
    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.

  5. Changes in B and T cell repertoire [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01095172


Locations
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United Kingdom
South West Transplant Centre
Plymouth, Devon, United Kingdom, PL6 8DH
East Kent Hospitals NHS Foundation Trust
Canterbury, Kent, United Kingdom, CT1 3NG
Glasgow Renal and Transplant Unit
Glasgow, United Kingdom, G11 6NT
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom, SE1 9RT
Central Manchester University Hospitals NHS Foundation Trust
Manchester, United Kingdom, M13 9WL
Sheffield Kidney Institute
Sheffield, United Kingdom, S5 7AU
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
Astellas Pharma Europe Ltd.
Investigators
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Principal Investigator: Nizam Mamode, MD FRCS(Gen) Guy's and St Thomas' NHS Foundation Trust

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Responsible Party: Nizam Mamode, Consultant Surgeon and Reader in Transplant Surgery, Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01095172     History of Changes
Other Study ID Numbers: RituxiRT
2009-017066-23 ( EudraCT Number )
95769119 ( Registry Identifier: ISRCTN )
9154 ( Registry Identifier: UK Clinical Research Network (CRN) Portfolio )
First Posted: March 30, 2010    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019

Keywords provided by Nizam Mamode, Guy's and St Thomas' NHS Foundation Trust:
Immunosuppression
Rituximab
B cell

Additional relevant MeSH terms:
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Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Rituximab
Tacrolimus
Prednisolone hemisuccinate
Prednisolone phosphate
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Immunosuppressive Agents
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents