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Efficacy and Safety of a Reduced Immunosuppression vs. Standard Triple Therapy in Senior Renal Transplant Recipients | Clinical Trials | Clareo Health

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Efficacy and Safety of a Reduced Immunosuppression vs. Standard Triple Therapy in Senior Renal Transplant Recipients

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

NCT02453867•Klemens Budde

View on ClinicalTrials.gov

Summary

Study purpose To establish efficacy and safety of a reduced immunosuppressive therapy with tacrolimus once daily for senior (\>65 years of age) renal transplant recipients

Detailed Description

Study outline Stable senior transplant recipients (\>65 years of age) participating in the European SENIOR transplant registry may enter the trial at month 3 post-transplant, if they fulfil all of the in- and none of the exclusion criteria. At this time patients will be randomized 1:1 either to continue Reference therapy: Tacrolimus once daily (Advagraf®) Mycophenolate (either MMF ≥1g/d or EC-MPS ≥720g/d) Steroids (≥5mg prednisolone or equivalent) or to Investigational therapy: Tacrolimus once daily (Advagraf®) Steroid stop at month 3 (tapering within 2 weeks) Mycophenolate stop at month 6

Eligibility

Age

65 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Males or females, aged ≥65 years and participating in the European SENIOR transplant registry
•2. Patients who received a renal allograft 3 - 3.5 months prior to randomization.
•3. Patient must have received primary or secondary renal allograft from a blood group compatible donor
•4. Standard criteria donors (SCD), expanded criteria donors (ECD), donors after cardiac death (DCD) and living donors (LD) are eligible
•5. Patients who are willing and able to participate in the study and from whom written informed consent has been obtained
•6. Patients on continuous standard triple therapy with tacrolimus once daily (Advagraf, trough level ≥5ng/ml) in combination with mycophenolate (either ≥1.0g/day MMF or ≥720mg/d EC-MPS) and steroids (≥5mg prednisolone or equivalent) since transplantation
•7. Stable graft function with serum creatinine ≤2.5 mg/dl.
•8. Patients with low to standard immunological risk, who had a PRA over 20% and no known donor specific antibodies (DSA) at transplantation

Exclusion Criteria

•1. Patient with mental dysfunction or inability to comply with the study protocol
•2. Patients, who - according to the investigator - require for medical reasons (e.g. previous rejections) continuous triple therapy or a different tacrolimus exposure
•3. Multi-organ recipients (other solid organ (e.g. pancreas) or bone marrow)
•4. Blood group ABO-incompatible allografts
•5. Patients who suffered from severe T-cell mediated rejection (over Banff II acute rejection), recurrent acute rejection (\>1 episode), or steroid resistant rejection post-transplant
•6. History of antibody-mediated rejection (acute or chronic)
•7. History of rejection 2 months prior to inclusion
•8. Documented presence of donor specific antibodies (DSA) according to local lab results at baseline
•9. Panel reactive antibody (PRA) \>20% prior to transplantation, measured according to local standard
•10. Patients receiving or having received Sirolimus, Everolimus, Azathioprine, Belatacept or Cyclophosphamide within 3 months prior to enrolment
+13 more criteria

Key Dates

Start Date

December 1, 2017

Primary Completion Date

July 1, 2018

Completion Date

July 1, 2019

Last Updated

August 9, 2017

Enrollment

400

ESTIMATED participants

Conditions

Immunosuppression After Renal Transplantation

Interventions

Reduced immunosuppression

OTHER

Tacrolimus

DRUG

mycophenolate

DRUG

Steroids

DRUG

Contacts

Lukas J Lehner, MD

CONTACT

004930450613559 lukas.lehner@charite.de

Klemens Budde, MD

CONTACT

004930450614086 klemens.budde@charite.de