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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00240994
First Posted: October 18, 2005
Last Update Posted: January 2, 2017
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.
Collaborator:
Cooperative Clinical Trials in Pediatric Transplantation
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
  Purpose
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.

Condition Intervention Phase
Kidney Failure, Chronic Kidney Transplantation Immunosuppression Drug: Alemtuzumab Drug: Tacrolimus Drug: Mycophenolate mofetil Drug: Sirolimus Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • 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.


Enrollment: 35
Study Start Date: January 2005
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00240994


Locations
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
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Cooperative Clinical Trials in Pediatric Transplantation
Investigators
Study Chair: William Harmon, MD Boston Children’s Hospital
  More Information

Additional Information:
Publications:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: SDY134
ImmPort study identifier is SDY134
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: SDY134
ImmPort study identifier is SDY134
Study summary, - schedule of events, -download packages et al.  This link exits the ClinicalTrials.gov site
Identifier: SDY134
ImmPort study identifier is SDY134

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00240994     History of Changes
Other Study ID Numbers: DAIT PC01
First Submitted: October 14, 2005
First Posted: October 18, 2005
Results First Submitted: September 13, 2012
Results First Posted: October 25, 2012
Last Update Posted: January 2, 2017
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
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.

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
End stage renal disease
Kidney transplantation
Renal transplantation
Kidney failure
Pediatric renal transplant recipients
Alemtuzumab
Campath
Mycophenolate mofetil
MMF
CellCept
Tacrolimus
Prograf
Sirolimus
Rapamycin

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Tacrolimus
Sirolimus
Everolimus
Mycophenolic Acid
Alemtuzumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Antibiotics, Antitubercular
Antitubercular Agents