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NCT00078559
The Use of Campath-1H, Tacrolimus, and Sirolimus Followed by Sirolimus Withdrawal in Renal Transplant Patients
Phase 1/Phase 2 trial testing Alemtuzumab in Kidney Transplantation in 10 participants. Completed in 1 February 2010.
1 February 2010
Quick facts
| Lead sponsor | University of Wisconsin, Madison |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 1 November 2003 |
| Primary completion | 1 February 2010 |
| Estimated completion | 1 February 2010 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Alemtuzumab
- Sirolimus (sirolimus) — full drug profile →
- Tacrolimus
- Kidney transplant
- Methylprednisolone (or equivalent)
- Acetaminophen
- Diphenhydramine (diphenhydramine) — full drug profile →
- Trimethoprim (TMP)/Sulfa (Bactrim, Septra)
- Valgancyclovir
- Acyclovir
- Pentamidine (PENTAMIDINE) — full drug profile →
- Clotrimazole (clotrimazole) — full drug profile →
- Nystatin
Conditions studied
- Kidney Transplantation — all drugs for Kidney Transplantation →
- Kidney Disease — all drugs for Kidney Disease →
Sponsor
University of Wisconsin, Madison
Who can join
Adults 18 to 65, any sex, with Kidney Transplantation or Kidney Disease. 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.
-
Number of Acute Rejections in All Enrolled Participants
Time frame: Four years post-transplant
Number of acute rejections\[1\] in all enrolled subjects from the time of transplantation to the end of the trial (four years post-transplant) 1. Acute rejection is defined as a biopsy-proven rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff\[2\] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for a
Sponsor's own description
Transplant rejection occurs when a patient's body does not recognize the new organ and attacks it. Patients who have kidney transplants must take drugs to prevent transplant rejection. Alemtuzumab is a man-made antibody used to treat certain blood disorders. The purpose of this study is to test the safety and effectiveness of using alemtuzumab in combination with two other drugs, sirolimus and tacrolimus, to prevent organ rejection after kidney transplantation. This study will also test whether this combination of medications will allow patients to eventually stop taking antirejection medications entirely. Study hypothesis: A new strategy of immunosuppression using alemtuzumab, tacrolimus, and sirolimus for human renal transplantation will permit a step-wise withdrawal from immunosuppressive drugs.
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 NCT00078559
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT05384756 — TMLI and Alemtuzumab for Treatment of Sickle Cell Disease · Phase 1 · active not recruiting
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Other recruiting trials for Kidney Transplantation
Currently open trials in the same condition.
- NCT07275632 — The Effects of Vonoprazan Fumarate on DGF Incidence in DD Kidney Transplant Recipients · Phase 1, PHASE2 · recruiting
- NCT06568549 — Reduced Immunosuppression in Older Renal Transplant Recipients With Trugraf®/TRAC Monitoring (RIOT Trial): A Prospective · Phase 4 · recruiting
- NCT06829719 — TTV-based mAnagement Of Long-term ImmunosuppreSsion in Kidney Transplantation · NA · recruiting
- NCT07316829 — TRAnscriptional Profile of Peripheral Blood Cells in Patient With Chronic Kidney and Lung Rejection: Correlation With Re · active not recruiting
- NCT06886256 — Prehabilitation for Kidney Transplant Candidates · NA · recruiting
Other University of Wisconsin, Madison trials
Trials by the same sponsor.
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- NCT07475104 — Redesigning Surgical Care for Patients in Wisconsin · NA · enrolling by invitation
- NCT07470723 — The ORIGIN-FH Study · NA · recruiting
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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 NCT00078559 (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 University of Wisconsin, Madison
- Last refreshed: 29 May 2018
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/NCT00078559.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing