At a glance
ClinicalIndex Comparison Record- ✓Receiving a primary kidney transplant from a cadaveric or non-HLA-identical living donor with 0-3 HLA-antigen mismatch
- ✓Kidney transplant only, no other organs
- ✓Able to take medications by mouth
- ✕HLA-identical living-donor kidney transplant
- ✕HLA-antigen mismatch greater than 3
- ✕Panel reactive antibody (PRA) value greater than 10% at any time prior to enrollment
- ✕Non-heart-beating donor allograft
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Use of Campath-1H, Tacrolimus, and Sirolimus Followed by Sirolimus Withdrawal in Renal Transplant Patients
In Brief
A Phase 2 clinical trial evaluating Alemtuzumab, Sirolimus, and 11 other interventions for Kidney Transplantation and Kidney Disease. Completed, enrolled 10 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
30mg intravenous infusion on days 0 (transplant), 1, and 2
2mg/day orally within 24-48 hrs post-transplant, and adjusted to achieve blood levels of 8-12 ng/mL for 1 year
2mg orally twice daily, on days 1-60
Kidney transplant with primary cadaveric or non-HLA-identical living donor kidney (0-3 HLA-antigen mismatch)
250 mg intravenous infusion 60 minutes prior to first dose of alemtuzumab
650 mg may be given 30-60 minutes prior to start of each infusion of alemtuzumab to prevent infusion related side effects such as fever, skin rash and pruritis
25 mg may be given 30-60 minutes prior to start of each infusion of alemtuzumab to prevent infusion related side effects such as fever, skin rash and pruritis
1 double strength tablet 3 times a week from day 1 through 1 year post-transplant.
Given orally beginning on day 1 for up to 10 days post-transplant (until participant discharged from hospital if prior to 10 days). Dose adjusted based on participants calculated creatinine clearance
400 mg orally twice daily or 800 mg orally four times daily (dose adjusted based on calculated creatinine clearance and cytomegalovirus antibody serologic status of donor and recipient) for a minimum of 3 months starting when valganciclovir discontinued.
300 mg/6 mL inhalation therapy once monthly for a total of 6 treatments. First treatment given within one week post-transplant for participants with a known allergy or intolerance to sulfa
10 mg orally four times daily for a minimum of 3 months post-transplant (subjects take either clotrimazole or nystatin, not both)
500,000 units/5 mL orally four times daily for a minimum of 3 months post-transplant (subjects take either nystatin or clotrimazole, not both)