![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
---|---|
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00240994 |
The purpose of this study is to evaluate the safety of alemtuzumab after kidney transplantation as part of a multitherapy regimen to prevent kidney graft loss and death and to avoid steroids and chronic use of calcineurin inhibitors in adolescents aged 1 to 20 years of age.
Condition | Intervention | Phase |
---|---|---|
Kidney Failure, Chronic Kidney Transplantation Immunosuppression |
Drug: Alemtuzumab Drug: Tacrolimus Drug: Mycophenolate mofetil Drug: Sirolimus |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | A Phase II Exploratory Study to Determine the Safety and Study the Immunomodulatory Functions of Induction Therapy With Campath-1H, Combined With Chronic Immunosuppression With MMF and Sirolimus |
Estimated Enrollment: | 35 |
Study Start Date: | January 2005 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental
Patients undergoing kidney transplantation
|
Drug: Alemtuzumab
Administered intravenously over a period of 2-3 hours. Two doses total, the first will be one day before transplant and the second will be on the day following transplantation. The dosage will be 0.3 mg/kg body weight (20 mg maximum). Pre-medication with Methylprednisolone, Acetaminiphen, and Benadryl will be administered before each dose.
Drug: Tacrolimus
Administered orally at a dose of 0.05-0.1 mg/kg twice daily, beginning 1-3 days following transplantation and continuing until weeks 8-12. Tacromlimus will be discontinued and a treatment regimen with Sirolimus will be initiated between weeks 8-12 but some overlap with these medications is possible.
Drug: Mycophenolate mofetil
Per recommendation
Drug: Sirolimus
Administered by either liquid or tablet every 12 hours from month 6 until month 24. Dosage will vary throughout the treatment course.
|
Kidney transplantation is widely considered to be the treatment of choice for children with End Stage Renal Disease (ESRD). Improvements in surgical techniques, donor selection, and immunosuppression practices, as well as the enhanced experience of specialized pediatric transplant teams, have all led to marked improvements in patient and kidney graft survival in infants and young children aged 1 to 10 years of age. However, young children now have more infections following transplant previously. Also, improved graft survival is not observed in adolescents aged 11 to 17 years of age. Some studies do indicate that the poor long term outcome of patient and kidney survival observed in this age group may be caused by noncompliance with immunosuppressive medications. Therefore, protocols that minimize the use of immunosuppressive medications while retaining kidney function are necessary for improving graft and patient survival in children. This study will evaluate the safety of a regimen containing alemtuzumab after kidney transplantation, followed by steroid avoidance and calcineurin inhibitor withdrawal in children and adolescents.
The accrual period is scheduled for 18 months. The study follow-up period will last 24 months. All participants enrolled will undergo this treatment schedule. All participants will receive intravenous (IV) alemtuzumab one day before transplantation and 1 day after transplantation. Mycophenolate mofetil (MMF) will be administered orally no later than 2 days after transplantation. Participants will begin to take oral tacrolimus twice a day 1 to 3 days after transplantation until Weeks 8 through 12 when sirolimus will be initiated. Sirolimus and MMF will be taken orally until Month 24.
Blood collection will occur at baseline, 1 day before transplant, at Days 1 and 3, at Weeks 2, 4, 6, 8, 10, and at Months 3 through 24. Scheduled renal biopsies will be performed at transplant, during Weeks 8 through 12 immediately before conversion to sirolimus, and at Months 6 and 24.
Ages Eligible for Study: | 1 Year to 20 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
University of California, San Francisco | |
San Francisco, California, United States, 94143-0116 | |
United States, Massachusetts | |
Children's Hospital, Boston | |
Boston, Massachusetts, United States, 02115 | |
United States, Pennsylvania | |
Children's Hospital, Philadelphia | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Washington | |
Children's Hospital and Regional Medical Center, Seattle | |
Seattle, Washington, United States, 98105 |
Study Chair: | William Harmon, MD | Children's Hospital Boston |
Responsible Party: | DAIT/NIAID ( Associate Director, Clinical Research Program ) |
Study ID Numbers: | DAIT PC01 |
Study First Received: | October 14, 2005 |
Last Updated: | September 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00240994 |
Health Authority: | United States: Federal Government |
End stage renal disease Kidney transplantation Renal transplantation Kidney failure Adolescents Campath-1H Alemtuzamab |
Mycophenolate mofetil MMF CellCept Tacrolimus Prograf Sirolimus Rapamycin |
Sirolimus Renal Insufficiency Clotrimazole Methylprednisolone Miconazole Tioconazole Mycophenolic Acid Kidney Failure, Chronic Tacrolimus |
Promethazine Urologic Diseases Renal Insufficiency, Chronic Alemtuzumab Mycophenolate mofetil Kidney Diseases Diphenhydramine Kidney Failure |
Anti-Bacterial Agents Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Antifungal Agents |
Therapeutic Uses Physiological Effects of Drugs Enzyme Inhibitors Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions |