Sirolimus vs Mycophenolate With Tacrolimus in Simultaneous Pancreas and Kidney Transplantation
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|ClinicalTrials.gov Identifier: NCT03582878|
Recruitment Status : Completed
First Posted : July 11, 2018
Last Update Posted : April 26, 2021
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 1||Drug: Sirolimus Oral Product Drug: Mycophenolate Mofetil||Phase 4|
MTOR (mammalian target of rapamycin) inhibitors represent group of immunosuppressive drugs with mechanism of T-cell blockade complementary to calcineurin inhibitors. The investigators presume that combination of sirolimus with tacrolimus will result in better survival of pancreatic and kidney grafts in simultaneous pancreas and kidney transplantations.
The study is proposed as a single-center extension of EUROSPK 002 trial originally started in 2004 by the EUROSPK Study Group. Recruitment of recipients started in 2004 with approval of EUROSPK 002. The patient recruitment has continued in a single center (Institute for Clinical and Experimental Medicine in Prague, Czech Republic) using the same inclusion and exclusion criteria. The recipients of primary kidney and pancreas transplantation have been randomized into 2 arms.
- In the intervention arm sirolimus is added to protocol at a dose of 5 mg immediately before transplantation, the dose is adjusted to maintained trough sirolimus trough levels between 5-10ng/ml.
- In the control arm mycophenolate mofetil was added to tacrolimus. Starting with 1g before transplantation, the dose has been increased to 1g bid afterwards.
Induction protocol at day 0. consists of ATG (antithymocyte globulin)induction 8mg/kg , Tacrolimus 0.05mg/kg, Methylprednisolone 125mg. Dosing of tacrolimus has been adjusted to maintain trough levels between 5-10ng/ml. ATG was administered at 3mg/kg on days 1.-3. Steroids have been gradually tapered from a dose of 20 mg prednison orally and withdrawn by 6w after transplantation.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||238 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Sirolimus or Mycophenolate With Tacrolimus on Survival of Pancreas and Kidney Grafts in Type 1 Diabetic Recipients After Simultaneous Pancreas and Kidney Transplantation|
|Actual Study Start Date :||January 1, 2004|
|Actual Primary Completion Date :||January 1, 2019|
|Actual Study Completion Date :||January 1, 2019|
Active Comparator: mycophenolate mofetil
mycophenolate mofetil dosing 1g before transplantation and 1g bid afterwards
Drug: Mycophenolate Mofetil
Mycophenolate Mofetil dosing 1g before transplantation and 1g bid afterwards
Other Name: CellCept
Sirolimus oral product Dosing 5mg orally 2-6h before transplantation Target trough levels between 5-10ng/ml
Drug: Sirolimus Oral Product
Oral form of sirolimus, daily dosing to achieve target trough levels between 5-10ng/ml since 1.day of transplantation
Other Name: Rapamune
- Pancreas graft survival [ Time Frame: 10 years ]Number of failed pancreatic grafts, failure is defined as graft removal, death, retransplantation or return to intensified insulin regimen.
- Recipient survival [ Time Frame: 10 years ]Long-term recipient survival evaluated with Kaplan-Meyer method
- Wound healing time [ Time Frame: 1year ]The number of days from transplantation to date of completely healed wound
- Kidney graft survival [ Time Frame: 10 years ]Number of failed kidneys evaluated with Kaplan-Meyer method. Failure defined as return to dialysis, death, retransplantation or graft removal
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): NCT03582878
|Institute for Clinical and Experimental Medicine|
|Prague, Czechia, 14021|
|Principal Investigator:||Frantisek Saudek, MD||Institute for Clinical and Experimental Medicine|