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Clinical Trials/EUCTR2011-000691-34-ES
EUCTR2011-000691-34-ES
Active, not recruiting
Phase 1

Single-center pilot study, prospective, open-label, to evaluate the efficacy and safety of immunosuppression low nephrotoxicity, based on the use of ATeGe-Fresenius in patients with renal insufficiency pretransplant liver

Dra Itxarone Bilbao. Servicio de Cirugía Hepatobiliopancreatica y Trasplantes. HUVH.0 sites40 target enrollmentJuly 21, 2011
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ConditionsRenal failure in liver transplantationMedDRA version: 14.0Level: PTClassification code 10024714Term: Liver transplantSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 14.0Level: LLTClassification code 10022467Term: Insufficiency renalSystem Organ Class: 10038359 - Renal and urinary disordersTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
DrugsATeGe-Fresenius 20 mg/ml concentrado para solución para perfusión

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Renal failure in liver transplantation
Sponsor
Dra Itxarone Bilbao. Servicio de Cirugía Hepatobiliopancreatica y Trasplantes. HUVH.
Enrollment
40
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 21, 2011
End Date
September 1, 2020
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Dra Itxarone Bilbao. Servicio de Cirugía Hepatobiliopancreatica y Trasplantes. HUVH.

Eligibility Criteria

Inclusion Criteria

  • •Pacientes que vayan a ser sometidos a un primer trasplante hepático de 18\-70 años de edad, sin contraindicación a priori para la realización de biopsias del aloinjerto, y con insuficiencia renal, que presenten niveles de creatinina sérica superiores a 1,5 mg/dl antes del trasplante hepático o valores de aclaramiento de creatinina estimado por MDRD \<60ml/min
  • •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 20
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 10

Exclusion Criteria

  • •Pacientes receptores de trasplante de múltiples órganos o con antecedentes de trasplante previo de cualquier otro órgano, receptores de un trasplante hepático procedente de un donante en asistolia o con incompatibilidad ABO respecto al donante, con infecciones concomitantes no controladas significativas y/o diarrea, vómito o úlcera péptica activa graves, recepción de vacunas con virus atenuados en las semanas previas al trasplante, leucopenia, trombocitopenia, y recuento linfocitario CD2\+/CD3\+ inferior a 10 células/μl.

Outcomes

Primary Outcomes

Not specified

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