Trials / Completed
CompletedNCT00861536
Comparison of ATG to Thymoglobuline in Renal Transplantation
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
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- University Hospital, Basel, Switzerland · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ATG Fresenius | Day 0: 9 mg/kg bw bolus Days 1-4: 3 mg/kg bw/d |
| DRUG | Thymoglobuline Genzyme | Day 0-3: 1.5 mg/kg bw/d |
Timeline
- Start date
- 2009-01-01
- Primary completion
- 2015-02-01
- Completion
- 2015-02-01
- First posted
- 2009-03-13
- Last updated
- 2015-04-14
Locations
1 site across 1 country: Switzerland
Source: ClinicalTrials.gov record NCT00861536. Inclusion in this directory is not an endorsement.