CNI-free "Bottom"-up Immunosuppression in Patients Undergoing Liver Transplantation (BUILT_01)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01023542|
Recruitment Status : Unknown
Verified June 2011 by University of Regensburg.
Recruitment status was: Recruiting
First Posted : December 2, 2009
Last Update Posted : July 1, 2011
|Condition or disease||Intervention/treatment||Phase|
|Renal Impairment Liver Transplantation Everolimus||Drug: delayed, low-dose CNI Drug: BU-CNI Drug: BU-Everolimus||Phase 2 Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A 3-Armed Prospective Randomized Controlled, Open-Labeled Phase II Trial to Evaluate Late Introduction of Cyclosporine or Everolimus Versus a 5-day Delay of Cyclosporine in Combination With MMF in Liver Transplant Recipients With MELD-Scores≥25|
|Study Start Date :||June 2011|
|Estimated Primary Completion Date :||July 2014|
|Estimated Study Completion Date :||December 2014|
Active Comparator: 1
Basiliximab 20 mg day 0 and 4 + MMF 2x1 g i.v./d from day 0 (will be switched to oral administration after 1 week) + low level cyclosporine [start at day 5 after OLT, trough-level 100-150 ng/mL (CsA)] + low-level steroids 1 mg/kg KG/d from day 0, elimination by month 6 after LTx.
Drug: delayed, low-dose CNI
Active Comparator: 2
Basiliximab 20 mg Tag 0 and 4 + MMF 2x1 g i.v./d from day 0 (will be switched to oral administration after 1 week) + low-level steroids 1 mg/kg KG/d from day 0, elimination by month 6 after LTx + low-level cyclosporine (start within 30 days after LTx; trough level 100-150ng/mL (CsA).
Basiliximab 20 mg Tag 0 and 4 + MMF 2x1 g i.v./d from day 0 (will be switched to oral administration after 1 week) + low-level steroids 1 mg/kg KG/d from day 0, elimination by month 6 after LTx + everolimus (start within 30 days after LTx; trough-level 6-10 ng/mL).
- The primary outcome measure of the trial is renal function at 12 months measured by estimated GFR using abbreviated MDRD formula. [ Time Frame: 1 year ]
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): NCT01023542
|Contact: Andreas A Schnitzbauer, MD||+49-941944 ext firstname.lastname@example.org|
|Contact: Susanne Melter, Study Nurse||+49-941944 ext email@example.com|
|Regensburg University Hospital||Recruiting|
|Regensburg, Bavaria, Germany, 93053|
|Contact: Andreas A Schnitzbauer, MD +49-941944 ext 6770 firstname.lastname@example.org|
|Principal Investigator:||Andreas A Schnitzbauer, MD||Regensburg University Hospital, Department of Surgery|
|Study Chair:||Hans J Schlitt, MD||Regensburg University Hospital Department of Surgery|