Phase 2
N=10
Combination Immunosuppressive Therapy to Prevent Kidney Transplant Rejection in Adults
Kidney Transplantation · Kidney Disease
Bottom Line
View on ClinicalTrials.gov: NCT00078559 ↗Enrolled (actual)
10
Serious AEs
50.0%
Results posted
Jul 2012
Primary outcome: Primary: Number of Acute Rejections in All Enrolled Participants — 1 Rejection Events
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Alemtuzumab (Drug); Sirolimus (Drug); Tacrolimus (Drug); Kidney transplant (Procedure); Methylprednisolone (or equivalent) (Drug); Acetaminophen (Drug); Diphenhydramine (Drug); Trimethoprim (TMP)/Sulfa (Bactrim, Septra) (Drug); Valgancyclovir (Drug); Acyclovir (Drug); Pentamidine (Drug); Clotrimazole (Drug); Nystatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Feb 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Acute Rejections in All Enrolled Participants |
1 | — |
| SECONDARY Number of Acute Rejections in All Enrolled Participants Following Sirolimus Withdrawal |
— | — |
| SECONDARY Number of Acute Rejections Between Initiation of Sirolimus Withdrawal and End of Study |
— | — |
| SECONDARY Time From Transplantation to Acute Rejection in Participants for Whom Sirolimus Withdrawal Was Not Initiated |
274 | — |
| SECONDARY Time From Transplantation to Acute Rejection in Participants for Whom Acute Rejection Occurred During the 1 Year Post-transplant Period |
274 | — |
| SECONDARY Number of Deaths Stratified by Sirolimus Withdrawal Status |
0; 0 | — |
| SECONDARY Number of Participants Who Experienced Graft Loss Stratified by Sirolimus Withdrawal Status |
0; 0 | — |
| SECONDARY Number of Severe Acute Rejections Stratified by Sirolimus Withdrawal Status |
0; 0 | — |
| SECONDARY Number of Participants Requiring Anti-lymphocyte Therapy for an Acute Rejection, Stratified by Sirolimus Withdrawal Status |
0; 0 | — |
| SECONDARY Number of Alemtuzumab Associated Adverse Events, Stratified by Sirolimus Withdrawal Status |
2; 8 | — |
| SECONDARY Number of Tacrolimus Associated Adverse Events, Stratified by Sirolimus Withdrawal Status |
0; 2 | — |
| SECONDARY Number of Sirolimus Associated Adverse Events, Stratified by Sirolimus Withdrawal Status |
2; 7 | — |
| SECONDARY Number of Side Effects of Conventional Immunosuppression, Stratified by Withdrawal Status |
2; 6 | — |
| SECONDARY Change in Renal Function as Measured by Serum Creatinine, Stratified by Withdrawal Status |
-4.2; -5.4 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Kidney transplant with primary cadaveric or non-Human Leukocyte Antigen (HLA)-identical living donor kidney (0-3 HLA-antigen mismatch)
- Receiving only a kidney and no other organs
- Able to take medications by mouth
- Willing to use acceptable methods of contraception
Exclusion Criteria
- Received 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
- Received a non-heart-beating donor allograft
- Received a kidney from a donor who is greater than 60 years of age
- End-stage Renal Disease (ESRD) due to Focal Segmental Glomulerosclerosis (FSGS)
- Previous kidney transplant
- Received multiorgan transplant
- Concomitant systemic corticosteroid therapy for other medical diseases
- Known hypersensitivity to alemtuzumab, tacrolimus, methylprednisolone, or sirolimus
- Human Immunodeficiency Virus (HIV) infected
- Hepatitis C virus infected
- Positive for hepatitis B surface antigen
- Received dual or en-bloc pediatric kidneys
- Anti-human Globulin (AHG) or T cell crossmatch positive
- Investigational drug within 6 weeks of study entry
- Known clinically significant cardiovascular or cerebrovascular disease
- Previous or current history of cancer or lymphoma. Patients with adequately treated basal or squamous cell skin carcinoma are not excluded.
- Clinically significant coagulopathy or a requirement for chronic anti-coagulation therapy precluding biopsy
- Cytomegalovirus (CMV)-negative recipient, if received kidney is from a CMV-positive donor
- History of a psychological illness or condition that, in the opinion of the investigator, may interfere with the study
- Graves disease. Patients who have been previously adequately treated with radioiodine ablative therapy are not excluded.
- Active systemic infections
- Platelets less than 100, 000 cells/mm^3 at study entry
- Pregnant or breastfeeding
Data sourced from ClinicalTrials.gov (NCT00078559). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.