Safety Use of ATeGe in Liver Transplant Recipients With Pre-transplant Renal Dysfunction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2020-02-29

Brief Summary

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Renal dysfunction in the context of liver transplantation is a major issue, with difficult patients' management and determining a worsened prognosis.

Physiopathologically pretransplant renal dysfunction is dependent on multifactorial causes, including hypoperfusion-derived functional renal insufficiency, hepatorenal syndrome or interstitial parenchymatous insufficiency. On top, intra- or post-transplant events, including hypoperfusion or calcineurin inhibitors nephrotoxicity may aggravate this situation.

At present MELD criteria favours allocation of organs to patients suffering from renal insufficiency, so at least 30% of the investigators liver transplant patients suffer from some degree of renal impairment pretransplant.

After liver transplant impaired renal function tends to recover partially or completely, unless advanced parenchymatous lesions are significantly involved as a major cause of renal dysfunction.

In this context, calcineurin inhibitors avoiding or sparing protocols may help in the recovery from renal insufficiency, improving long-term prognosis. The use of anti-CD25 antibodies is a good option, but provides a limited antirejection prophylaxis, limiting the use of these antibodies to a reduced cohort of liver transplant patients.

Polyclonal antibodies might provide an advantage in management of liver transplant patients with renal insufficiency, without increasing acute rejection episodes of the allograft efficacy and security evaluation of low nephrotoxicity immunosuppression, based on the use of ATeGe, in liver transplant candidates with pre-transplant renal dysfunction.

The aim of this study is to evaluate the efficacy and security use of immunosuppression based on ATeGe in liver transplant recipients with pre-transplant renal dysfunction.

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Detailed Description

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Conditions

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Renal Insufficiency

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Basiliximab

Historical comparable cohort treated with Basiliximab 20mg iv administered at 0 and 4th day post-transplant

Group Type NO_INTERVENTION

No interventions assigned to this group

ATeGe-Fresenius

Group Type ACTIVE_COMPARATOR

ATeGe-Fresenius

Intervention Type DRUG

Administered at 1 , 3, 5 and 7 day post-transplant at 2-3mg/kg with dose adjustment according to CD2/CD3 levels

Interventions

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ATeGe-Fresenius

Administered at 1 , 3, 5 and 7 day post-transplant at 2-3mg/kg with dose adjustment according to CD2/CD3 levels

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Cristina Dopazo Taboada

Consultant and Liver Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR