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Safety in Immunomodulatory Functions of Alemtuzumab (Campath) in Pediatric Kidney Transplantation Recipients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00240994
Recruitment Status : Completed
First Posted : October 18, 2005
Results First Posted : October 25, 2012
Last Update Posted : January 2, 2017
Sponsor:
Collaborator:
Cooperative Clinical Trials in Pediatric Transplantation
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Tracking Information
First Submitted Date  ICMJE October 14, 2005
First Posted Date  ICMJE October 18, 2005
Results First Submitted Date  ICMJE September 13, 2012
Results First Posted Date  ICMJE October 25, 2012
Last Update Posted Date January 2, 2017
Study Start Date  ICMJE January 2005
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2012)
The Proportion of Participants With Graft Loss or Death Within 12 Months Post Kidney Transplantation [ Time Frame: Up to one year post kidney transplantation procedure ]
Graft loss is defined as the need for dialysis for more than 30 days duration, allograft nephrectomy, or the decision to withdraw immunosuppression due to graft failure.
Original Primary Outcome Measures  ICMJE
 (submitted: October 14, 2005)
Proportion of participants who have graft loss or death within 12 months after transplantation
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2005)
  • Longer term patient and graft survival
  • Occurrence, severity, and treatment for acute and humoral rejection
  • incidence of chronic allograft nephropathy at Months 6 and 24
  • change in serum creatinine 72 hours after transplantation and between Months 6 and 12
  • kidney function at Month 12
  • Incidence and severity of hyperlipidemia, hypertension, anemia, leukopenia, neutropenia, and the requirement for treatment
  • infectious complications including bacterial, viral, and fungal infections
  • Surgical complications
  • Incidence and duration of re-hospitalizations after transplantation
  • Incidence of biopsy proven post-transplant lymphoproliferative disorder (PTLD)
  • Incidence of opportunistic infections, especially cytomegalovirus (CMV) and Epstein-Barr virus (EBV) viremia
  • Treatment for viremia and disease
  • Incidence of delayed graft function
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety in Immunomodulatory Functions of Alemtuzumab (Campath) in Pediatric Kidney Transplantation Recipients
Official Title  ICMJE A Phase II Exploratory Study to Determine the Safety and Study the Immunomodulatory Functions of Induction Therapy With Campath, Combined With Chronic Immunosuppression With Mycophenolate Mofetil and Sirolimus
Brief Summary 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 pediatric renal transplant recipients 1 to 20 years of age.
Detailed Description

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 ages 1 to 10. However, young children now have more infections following transplant previously. Also, improved graft survival is not observed in pediatric renal transplant recipients 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 pediatric renal transplant recipients 1 to 20 years of age.

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: 1.) All participants will receive intravenous alemtuzumab one day before transplantation and 1 day after transplantation. 2.) Mycophenolate mofetil (MMF) will be administered orally no later than 2 days after transplantation. 3.) Participants will begin to take oral tacrolimus twice a day 1 to 3 days after transplantation until Weeks 8 through 12 when 4.) Sirolimus will be initiated. 5.) 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 kidney (renal) biopsies will be performed at transplant, during Weeks 8 through 12, immediately before conversion to sirolimus, and at Months 6 and 24.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Kidney Failure, Chronic
  • Kidney Transplantation
  • Immunosuppression
Intervention  ICMJE
  • 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. Pre-medication with methylprednisolone, acetaminophen, and Benadryl will be administered before each dose.
    Other Names:
    • Campath
    • Campath- 1H
  • 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. Tacrolimus will be discontinued and a treatment regimen with sirolimus will be initiated between weeks 8-12 but some overlap with these medications is possible.
    Other Name: Prograf
  • Drug: Mycophenolate mofetil
    Per recommendation
    Other Name: CellCept
  • Drug: Sirolimus
    Administered by either liquid or tablet every 12 hours from month 6 until month 24. Dosage will vary throughout the treatment course.
    Other Name: Rapamycin
Study Arms  ICMJE Experimental: Alemtuzumab (Campath)
In this open-label, single-arm trial , participants will be administered a 0.3 mg/kg dose of alemtuzumab (Campath) intravenously one day prior to kidney transplantation and one day post kidney transplantation. Participants will then receive a maintenance immunosuppressive regimen of tacrolimus and mycophenolate mofetil (MMF) for 8 to 12 weeks, followed by sirolimus and MMF until 24 months post transplantation.
Interventions:
  • Drug: Alemtuzumab
  • Drug: Tacrolimus
  • Drug: Mycophenolate mofetil
  • Drug: Sirolimus
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 14, 2005)
35
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2009
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Between the ages of 1 to 20 (prior to 21st birthday)
  • End Stage Renal Disease
  • Necessity of kidney transplant
  • First kidney transplant received from a living donor
  • A living kidney donor identified
  • No known contraindications to therapy with alemtuzumab
  • Negative pregnancy test before study entry
  • Willing to use approved methods of contraception for the duration of the study, 6 weeks after discontinuation of MMF, and 12 weeks after discontinuation of sirolimus
  • Informed consent from participant, parent, or guardian
  • Current vaccinations, including varicella-zoster (VZV) vaccine, before study enrollment

Exclusion Criteria:

  • Recipient of a deceased donor kidney transplant
  • Multiorgan transplant
  • History of prior organ transplantation
  • Participant sensitized to greater than 0% Panel Reactive Antibody (PRA) within 4 weeks before study enrollment. (If participant receives a blood transfusion status post PRA test, then the PRA must be repeated within 1 week of transplantation)
  • Participants with human leukocyte antigen (HLA) identical living related donors
  • History of primary focal segmented glomerulosclerosis
  • History of other disorders requiring continuous maintenance steroids or calcineurin inhibitors
  • Active systemic infection at time of transplant
  • History of malignancy
  • Infected with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
  • Contraindication to receive tacrolimus, sirolimus, MMF, or monoclonal antibody therapy
  • Use of investigational drugs within 4 weeks before study enrollment
  • Recipient of any licensed or investigational live attenuated vaccine(s) within 2 months before study enrollment
  • Family history of high cholesterol
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 20 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00240994
Other Study ID Numbers  ICMJE DAIT PC01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Participant level data and additional relevant materials are available to the public in the Immunology Database and Analysis Portal (ImmPort). ImmPort is a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.
Responsible Party National Institute of Allergy and Infectious Diseases (NIAID)
Study Sponsor  ICMJE National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators  ICMJE Cooperative Clinical Trials in Pediatric Transplantation
Investigators  ICMJE
Study Chair: William Harmon, MD Boston Children’s Hospital
PRS Account National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP