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Single Centre, Prospective, Open, Non Controlled, Pilot Study for Efficacy and Security Evaluation of Low Nephrotoxicity Immunosuppression, Based on the Use of ATeGe in Liver Transplant Recipients With Pre-transplant Renal Dysfunction


Phase 3
18 Years
70 Years
Open (Enrolling)
Both
Renal Insufficiency

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Trial Information

Single Centre, Prospective, Open, Non Controlled, Pilot Study for Efficacy and Security Evaluation of Low Nephrotoxicity Immunosuppression, Based on the Use of ATeGe in Liver Transplant Recipients With Pre-transplant Renal Dysfunction


Inclusion Criteria:



- Patients with moderate pre-transplant renal dysfunction as defined serum creatinine
levels higher than 1.5 mg/dl or eGFR (MDRD-4) <60ml/min.

- First liver transplant, including splits liver transplant.

- Patients aged 18-70 years

- Without a prior contraindication for protocol biopsy of allograft.

Exclusion Criteria:

- Multiorgan transplantation and/or liver transplant from DCD and/or with ABO
incompatibility.

- Uncontrolled concomitant infections (including HIV seropositivity) and/or diarrhoea,
vomiting or active gastric ulcer.

- Fulminant hepatic insufficiency as first indication for liver transplant

- Hemodynamic instability prior to liver transplant.

- Recipient presenting present or previous neoplasia, except for non-metastatic basal
or squamous cutaneous carcinoma or localized hepatocarcinoma with diameter <5 cm or
< 3 known lesions with diameter <3 cm.

- Intolerance to study medication.

- Patients having received vaccination with attenuated living vaccines within the
previous 4 weeks.

- Severe leukopenia (< 1.2 X 10E9/L) and/or thrombocytopenia (< 50x10E9/L) and/or
lymphocyte counts (CD2+/CD3+) less than 10 cells/µl.

- Significant comorbidity.

- Breastfeeding or female patients at fertile age without negative pregnancy test and
accepting the use of reliable fertility control method.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

Renal function improvement after liver transplant

Outcome Description:

Creatinine (mg/dL) and MDRD Glomerular Filtrate Rate (ml/min/1.73m2) will be measured following the time frame described above

Outcome Time Frame:

Measurement will be performed at 1st, 2nd, 3rd, 4th, 5th, 6th, 7th, 14th and 28th day post-transplant, and 2nd, 3rd, 6th and 12th month post-transplant

Safety Issue:

Yes

Principal Investigator

ITXARONE BILBAO, PhD/MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of HPB Surgery and Transplants, Hospital Vall d´Hebron (Barcelona, Spain)

Authority:

Spain: Comité Ético de Investigación Clínica

Study ID:

ATG-IRA-HVH.10

NCT ID:

NCT01453218

Start Date:

October 2011

Completion Date:

Related Keywords:

  • Renal Insufficiency
  • Renal insufficiency
  • Liver transplant
  • Acute rejection
  • Infections
  • Hepatitis C recurrence
  • Renal Insufficiency

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