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NCT Number: NCT01453218

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

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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Key information

Conditions

Renal Insufficiency Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of HPB Surgery and Transplants, Hospital Vall d´Hebron

Barcelona, 08035, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ATeGe-Fresenius

Drug

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

Primary outcomes

  1. Renal function improvement after liver transplant

    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

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

Secondary outcomes

  1. Incidence of biopsy proven acute cellular rejection.

    Time frame: Evaluation at 1st , 3rd, 6th, 9th and 12th month post-transplant

    If liver dysfunction is detected, percutaneous liver biopsy will be performed and histological severity will be assed following BANF criteria

  2. Patient and graft survival rates after 12 months, causes of death and retransplant

    Time frame: Evaluation at 1st , 3rd, 6th, 9th and 12th month post-transplant

  3. Relationship between ATeGe doses, immunological variables (lymphocyte counts) and clinical adverse events (acute rejection,infections, HCV recurrence and de novo tumor)

    Time frame: Evaluation at 1st , 3rd, 6th, 9th and 12th month post-transplant

  4. Incidence and severity of HCV infection recurrence, based on clinical and histological criteria.

    Time frame: Once liver dysfunction is detected and one year post-transplant by protocol.

  5. Evaluation of metabolic complications (diabetes mellitus, arterial hypertension and dyslipidemia)

    Time frame: Evaluation at 1st , 3rd, 6th, 9th and 12th month post-transplant

Sponsors and collaborators

Lead sponsor

Hospital Vall d'Hebron

Other

Collaborators

  • Hospital Universitari Vall d'Hebron Research Institute

Registry information

Official study title

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

Acronym: ATG_HVH

Important dates

Study start
2011
Primary completion
2020
Study completion
2020
First posted
Oct 17, 2011
Registry last updated
Feb 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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