Comparison of ATG to Thymoglobuline in Renal Transplantation

Transplantation, Kidney Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00861536
• Other study ID #: 82/06
• Status: Completed
• Phase: Phase 4
• First received: March 12, 2009
• Last updated: April 13, 2015
• Start date: January 2009
• Est. completion date: February 2015

Study information

• Verified date: April 2015
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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.

2. Patient receives a renal allograft only.

3. Female patients of child bearing age agree to maintain effective birth control practice during the study.

4. Patient has been fully informed and has given written or independent person witnessed oral informed consent.

Exclusion Criteria:

1. Patient is pregnant or breastfeeding.

2. Patient has a low immunological risk constellation, defined by receiving a kidney from a HLA-identical related living donor.

3. Patient and donor have a positive T-cell crossmatch.

4. Patient and donor are ABO incompatible.

5. Patient with combined transplantation.

6. Age of donor >75 years.

7. Cold ischemia time >40 hours.

8. Patient has leucopenia, defined as having at transplantation less than 3000/mm3 leukocytes.

9. Patient has thrombocytopenia, defined as having at transplantation less than 75000/mm3 thrombocytes.

10. Patient is allergic or intolerant to ATG-Fresenius S, Thymoglobulin, steroids, Tacrolimus or MMF.

11. EBV risk constellation (recipient EBV negative and donor EBV positive).

12. Patient or donor is known to be HIV positive.

13. 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.

14. 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.

15. Patient has uncontrolled concomitant infections and/or severe diarrhea, vomiting, or active peptic ulcer.

16. Patient is unlikely to comply with the visits schedule in the protocol.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Transplantation, Kidney

Intervention

Drug:
• ATG Fresenius
Day 0: 9 mg/kg bw bolus Days 1-4: 3 mg/kg bw/d
• Thymoglobuline Genzyme
Day 0-3: 1.5 mg/kg bw/d

Locations

Country	Name	City	State
Switzerland	University Hospital Basel, Transplantation Immunology and Nephrology	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events		Daily	Yes
Secondary	Rejection		Daily	No
Secondary	Graft function		Daily	Yes
Secondary	Patient survival		Daily	Yes
Secondary	Graft survival		Daily	No