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Clinical Trials/EUCTR2007-003561-40-DE
EUCTR2007-003561-40-DE
Active, not recruiting
Not Applicable

A Pilot Study to Determine the Safety and Efficacy of Induction-Therapy, De Novo MPA and Delayed mTOR-Inhibition in Liver Transplant Recipients with Impaired Renal Function - PATRON-Study - CNI-free Prevention of Rejection in Liver Transplant Patients with Impaired Renal Function

Regensburg University Medical Center, Department of Surgery0 sites29 target enrollmentFebruary 26, 2008
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ConditionsEvaluation of the safety and efficacy of CNI-free immunosuppressive treatment of patients undergoing liver transplantation with a preexisting renal impairment.MedDRA version: 9.1Level: LLTClassification code 10062237Term: Renal impairmentMedDRA version: 9.1Level: LLTClassification code 10024716Term: Liver transplantationMedDRA version: 9.1Level: LLTClassification code 10062016Term: Immunosuppression
DrugsRapamuneSimulectCellCept

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Evaluation of the safety and efficacy of CNI-free immunosuppressive treatment of patients undergoing liver transplantation with a preexisting renal impairment.
Sponsor
Regensburg University Medical Center, Department of Surgery
Enrollment
29
Status
Active, not recruiting
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 26, 2008
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Regensburg University Medical Center, Department of Surgery

Eligibility Criteria

Inclusion Criteria

  • •1\.Patients undergoing primary liver transplantation.
  • •2\.Patients with a hepatorenal syndrome
  • •3\.eGFR \< 50 ml/min at the time point of transplantation
  • •4\.Serum creatinine levels \> 1\.5 mg/dL at the time\-point of transplantation
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • •1\.Patients with pre\-transplant renal replacement therapy \> 14 days.
  • •2\.Patients with hepatocellular carcinoma.
  • •3\.Patients with a reason for renal impairment other than a hepatorenal syndrome.
  • •4\.Patients with a known hypersensitivity to mTOR\-inhibitors.
  • •5\.Patients with a known hypersensitivity to mycophenolate acid.
  • •6\.Patients with a known hypersensitivity to anti CD 25\-monoclonal antibodies.
  • •7\.Patients with platelets \< 50\.000/nl prior to initiation of therapy with mTOR inhibition.
  • •8\.Patients with triglycerides \> 350 mg/dl and cholesterol \> 300 mg/dl refractory to optimal medical treatment prior to initiation of therapy with mTOR inhibition.
  • •9\.Severe systemic infections and wound\-healing disturbances.
  • •10\.Multiple organ graft recipients.

Outcomes

Primary Outcomes

Not specified

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