REDUCE Protocol version 8.1
Research type
Research Study
Full title
REDUCE - Multicenter, prospective, randomized study investigating the efficacy and safety of a reduced immunosuppressive therapy with tacrolimus once daily in comparison to standard triple immunosuppression in senior renal transplant recipients
IRAS ID
231328
Contact name
Chris Dudley
Contact email
Sponsor organisation
Charité Universitätsmedizin, Berlin
Eudract number
2014-002643-18
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
CET010, Centre for Evidence in Transplantation
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
The purpose of this study is to establish the efficacy and safety of a reduced drug regimen (combination of different drugs) for the prevention of graft rejection. Drugs, which inhibit the immune system for preventing rejection are called “immunosuppressants”.
Well-dosed immunosuppressants are key for the success of organ transplantation. It is necessary to take such medication to prevent rejection and ultimately prevent the loss of the transplanted organ. Several drug regimens are able to suppress the patient’s immune system effectively from rejecting the transplanted kidney. Initially a more powerful inhibition of the immune system (called “immunosuppression”) is necessary and today 3, or 4 medicines are given at the time of transplantation in order to suppress the immune system. Some of the medicines currently used are called “tacrolimus” (e.g. Advagraf®), “mycophenolate” (e.g. CellCept®, Myfenax® or Myfortic®) and corticosteroids (also called “Cortison” or “steroids” e.g. Prednisolone or Methylprednisolone). Despite the desired and positive effects of immunosuppression, these drugs can cause unwanted side effects such as an increased risk of infection or malignancy, stomach problems, diarrhea, diabetes, high blood pressure, high blood lipids, low red (called anemia) or white blood cells and toxicity to the transplanted kidney.
The current standard immunosuppressive regimen as recommended by international guidelines consists of three drugs: tacrolimus, mycophenolate and corticosteroids (see above). This drug combination is very successful in suppressing acute graft rejection, leading to good short-term outcomes. While these medications are well tolerated by most patients, the use of three immunosuppressants may lead to multiple side effects as pointed out above. Evidently, most side effects are well manageable (e.g. by dose reductions), but there is a clear need to improve the drug regimens after kidney transplantation in order to avoid side effects instead of treating side effects.
Because elderly kidney transplant recipients (over the age of 65 years) are more vulnerable to those side effects, it is of particular importance to design a tailored immunosuppressive regimen for this population. Therefore, it is the aim of this study to compare the standard immunosuppressive regimen (in this case continued therapy with tacrolimus (Advagraf®), mycophenolate (e.g. CellCept®, Myfenax® or Myfortic®) and steroids with a reduced immunosuppressive drug regimen.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
18/SC/0370
Date of REC Opinion
3 Oct 2018
REC opinion
Further Information Favourable Opinion