Comparison of ATG to Thymoglobuline in Renal Transplantation

NCT00861536 | Completed Phase 4

• 1 other identifier: 82/06
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Transplantation, Kidney

Keywords

risk factors; immunology

Outcome Measures

Primary Outcomes (1)

• Adverse events

  Daily

Secondary Outcomes (4)

• Rejection

  Daily

• Graft function

  Daily

• Patient survival

  Daily

• Graft survival

  Daily

Study Arms (2)

ATG Fresenius

EXPERIMENTAL

Drug: ATG Fresenius

Thymoglobuline Genzyme

ACTIVE COMPARATOR

Drug: Thymoglobuline Genzyme

Interventions

ATG Fresenius DRUG

Day 0: 9 mg/kg bw bolus Days 1-4: 3 mg/kg bw/d

ATG Fresenius

Thymoglobuline Genzyme DRUG

Day 0-3: 1.5 mg/kg bw/d

Thymoglobuline Genzyme

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel, Transplantation Immunology and Nephrology

Basel, 4031, Switzerland

Location

Study Officials

• Juerg Steiger, MD,Prof

  University Hospital Basel, Transplantation Immunology and Nephrology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2009
• First Posted: March 13, 2009
• Study Start: January 1, 2009
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: April 14, 2015

Record last verified: 2015-04

Locations

CH (1)