Comparison of ATG to Thymoglobuline in Renal Transplantation - Full Text View

Sponsored by:	University Hospital, Basel, Switzerland
Information provided by:	University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:	NCT00861536

Purpose

An open, multicenter, randomised, parallel group pilot study to investigate two different polyclonal rabbit immunoglobulin preparations for safety and efficacy: A comparison of ATG-Fresenius S to Thymoglobulin in prophylaxis for immunological high risk patients following renal transplantation. This non-inferiority trial shall demonstrate that ATG-Fresenius S is as efficacious as Thymoglobulin but has a better tolerance and fewer side effects.

Condition	Intervention	Phase
Transplantation, Kidney	Drug: ATG Fresenius Drug: Thymoglobuline Genzyme	Phase IV

MedlinePlus related topics: Kidney Transplantation

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	An Open, Multicenter, Randomised, Parallel Group Pilot Study to Investigate Two Different Polyclonal Rabbit Immunoglobulin Preparations for Safety and Efficacy:A Comparison of ATG-Fresenius S to Thymoglobulin in Prophylaxis for Immunological High Risk Patients Following Renal Transplantation

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:

Adverse events [ Time Frame: Daily ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Rejection [ Time Frame: Daily ] [ Designated as safety issue: No ]
Graft function [ Time Frame: Daily ] [ Designated as safety issue: Yes ]
Patient survival [ Time Frame: Daily ] [ Designated as safety issue: Yes ]
Graft survival [ Time Frame: Daily ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	January 2009
Estimated Study Completion Date:	January 2013
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
ATG: Experimental	Drug: ATG Fresenius Day 0: 9 mg/kg bw bolus Days 1-4: 3 mg/kg bw/d
Thymoglobuline: Active Comparator	Drug: Thymoglobuline Genzyme Day 0-3: 1.5 mg/kg bw/d

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Recipients, who are at least 18 years or older and have a high immunological risk defined by:

The presence of at least one donor-specific antibody (class I and/or II) detected and specified by flow-technology (FlowPRA and single antigen beads), which are
- For class I below the threshold of detection of a current CDC T-cell-/ and B-cell cross-match
- For class II below the threshold of detection of a current CDC B-cell cross-match.
Patient receives a renal allograft only.
Female patients of child bearing age agree to maintain effective birth control practice during the study.
Patient has been fully informed and has given written or independent person witnessed oral informed consent.

Exclusion Criteria:

Patient is pregnant or breastfeeding.
Patient has a low immunological risk constellation, defined by receiving a kidney from a HLA-identical related living donor.
Patient and donor have a positive T-cell crossmatch.
Patient and donor are ABO incompatible.
Patient with combined transplantation.
Age of donor >75 years.
Cold ischemia time >40 hours.
Patient has leucopenia, defined as having at transplantation less than 3000/mm3 leukocytes.
Patient has thrombocytopenia, defined as having at transplantation less than 75000/mm3 thrombocytes.
Patient is allergic or intolerant to ATG-Fresenius S, Thymoglobulin, steroids, Tacrolimus or MMF.
EBV risk constellation (recipient EBV negative and donor EBV positive).
Patient or donor is known to be HIV positive.
Patient has a liver disease, defined as continuously having ASAT (SGOT) and/or ALAT (SGPT) levels greater than 3fold of the upper value of the normal range of the investigational site during the past 28 days.
Patient with malignancy or history of malignancy <2 years, except non metastatic basal or squamous cell carcinoma of the skin that has been treated successfully.
Patient has uncontrolled concomitant infections and/or severe diarrhea, vomiting, or active peptic ulcer.
Patient is unlikely to comply with the visits schedule in the protocol.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00861536

Contacts

Contact: Juerg Steiger, Prof

+41 61 265 44 04

jsteiger@uhbs.ch

Locations

Switzerland
University Hospital Basel, Transplantation Immunology and Nephrology	Recruiting
Basel, Switzerland, 4031
Contact: Juerg Steiger, Prof +41 61 265 44 04 jsteiger@uhbs.ch
Principal Investigator: Juerg Steiger, Prof

Sponsors and Collaborators

University Hospital, Basel, Switzerland

Investigators

Principal Investigator:

Juerg Steiger, Prof

University Hospital Basel, Transplantation Immunology and Nephrology

More Information

No publications provided

Responsible Party:	University Hospital Basel ( Prof. Juerg Steiger )
Study ID Numbers:	82/06
Study First Received:	March 12, 2009
Last Updated:	March 12, 2009
ClinicalTrials.gov Identifier:	NCT00861536 History of Changes
Health Authority:	Switzerland: Swissmedic

Keywords provided by University Hospital, Basel, Switzerland:

risk factors
immunology

Study placed in the following topic categories:

Antibodies
Immunoglobulins

ClinicalTrials.gov processed this record on May 07, 2009