Last reviewed · How we verify
NCT00316810
An Open-label, Randomized, Prospective Study to Investigate the Safety and Efficacy of Campath-1H as an Induction Agent in Combination With Tacrolimus Monotherapy Compared to Short-course ATG-induction in Combination With Tacrolimus, Mycophenolate Mofetil and Short-term Steroids Application in de Novo SPK Transplanted Diabetic Patients
Phase 3 trial testing Alemtuzumab in Pancreas-Kidney Transplantation in 30 participants. Completed in 1 June 2011.
1 February 2011
Quick facts
| Lead sponsor | Dr. Claudia Bösmüller |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 1 April 2006 |
| Primary completion | 1 February 2011 |
| Estimated completion | 1 June 2011 |
| Sites | 1 location across Austria |
Drugs / interventions tested
- Alemtuzumab (ALEMTUZUMAB) — full drug profile →
- Rabbit Anti-Human Thymocyte Globulin — full drug profile →
Conditions studied
- Pancreas-Kidney Transplantation — all drugs for Pancreas-Kidney Transplantation →
Sponsor
Dr. Claudia Bösmüller
Who can join
Adults 18 to 55, any sex, with Pancreas-Kidney Transplantation. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Biopsy-proven (Kidney) rejection episodes
Time frame: Year 1
Sponsor's own description
The purpose of this study is to determine and compare the efficacy of Campath-1H/Tacrolimus versus ATG/Tacrolimus/MMF therapy in conjunction with initial short-term steroids in Type 1-diabetic patients undergoing simultaneous pancreas-kidney allograft transplantation as well as to evaluate the safety of Campath-1H/Tacrolimus versus ATG/Tacrolimus/MMF in terms of drug-related complications and immunosuppression-associated complications.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00316810
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Alemtuzumab
Trials testing the same drug.
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- NCT06872333 — Allo HSCT for High Risk Hemoglobinopathies · Phase 2 · recruiting
- NCT05501756 — Precision Alemtuzumab Dosing for Allogeneic Hematopoietic Cell Transplantation · Phase 2 · recruiting
- NCT05384756 — TMLI and Alemtuzumab for Treatment of Sickle Cell Disease · Phase 1 · active not recruiting
- NCT06310343 — ADAs to Alemtuzumab · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00316810 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Dr. Claudia Bösmüller
- Last refreshed: 18 June 2012
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00316810.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing