Pediatric Kidney Transplant Study of Sirolimus, Mycophenolate Mofetil, and Corticosteroids vs Calcineurin Inhibitor Based Immunosuppression

NCT00555373

Last updated date
Study Location
Pediatric Nephrology of Alabama
Birmingham, Alabama, 35205, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Transplant
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0-19
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

at Transplant:

- Age < 19 years (up to the day of the 19th birthday)

- Panel Reactive Antibody Level (PRA) <20% (Flow cytometry method)

- Recipient of first living donor or deceased donor renal transplantation

- Signed and dated informed consent (per local IRB standards)

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

at Transplant:


- Recipients of multi-organ transplants (e.g. kidney/pancreas transplant, etc.)


- Peak PRA > 20% at any time


- Recipient of en-bloc kidneys


- Recipient of an organ from an HLA identical donor or a non-heart beating donor


- Pregnant or lactating


- Positive for HIV or an immunodeficiency virus


- History of malignancy


- Use of investigational agents within 4 weeks prior to transplantation


- Current use of terfenadine, cisapride, astemizole, or pimozide (unless discontinued
before administration of SRL)


- Known hypersensitivity to sirolimus


- Known hypersensitivity to Prograf, Cellcept, prednisone, Cremophor, HCO-60, or murine
products

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Renal TransplantPediatric Kidney Transplant Study of Sirolimus, Mycophenolate Mofetil, and Corticosteroids vs Calcineurin Inhibitor Based Immunosuppression
NCT00555373
  1. Birmingham, Alabama
  2. Los Angeles, California
  3. Stanford, California
  4. Atlanta, Georgia
ALL GENDERS
0+
years
MULTIPLE SITES
Renal TransplantIntravenous Voriconazole in Patients With Renal Compromise
NCT00332410
  1. Pittsburgh, Pennsylvania
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Renal TransplantCalcineurin Inhibitor Based Immunosuppression Withdrawal
NCT02117596
  1. Birmingham, Alabama
  2. Los Angeles, California
  3. Stanford, California
  4. Atlanta, Georgia
ALL GENDERS
0+
years
MULTIPLE SITES
Renal TransplantStudy Evaluating Rapamune® Maintenance Regimen
NCT00478608
ALL GENDERS
13 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Pediatric Kidney Transplant Study of Sirolimus, Mycophenolate Mofetil, and Corticosteroids vs Calcineurin Inhibitor Based Immunosuppression
Official Title  ICMJE Novel Pilot Trial of Sirolimus, Mycophenolate Mofetil, and Corticosteroids Versus a Historic Control Population Receiving Calcineurin Inhibitors Based Immunosuppression
Brief Summary

Damage and scarring of a transplanted kidney has become the most common cause of loss of the transplanted kidney. This kidney damage is a complex process caused by many factors including injury during obtaining and transplanting the kidney, injury from the immune system, injury from infections, and injury from drugs used to stop rejection. This injury leads to scars that decrease the kidney's ability to function properly, and over time the kidney is lost. Prograf® (tacrolimus) has been one of the main drugs used to prevent rejection. However, when used over time it has been shown to cause chronic damage and scarring in the transplanted kidney.

The purpose of this experimental study is to determine whether children can safely be withdrawn from Prograf® after transplantation and changed to Rapamycin® (sirolimus). Recent research studies in adult transplantation have demonstrated that with the use of Rapamycin® (sirolimus), it is possible to discontinue the use of Prograf (tacrolimus) with no increase in rejection, with decreased scarring in the kidney, and with improvements in kidney function and survival of the kidney. A total of 50 children will enroll in this study at university centers around the country. This study will last about 3 years.

Detailed Description Advances in immunosuppressive therapies in pediatrics have been associated with rapidly falling incidence of acute rejection and improving allograft survival. In recent analyses of the NAPRTCS database, acute rejection is no longer the most common cause of hospitalization or allograft failure. Chronic rejection has now become the most common cause of allograft failure and accounts for over 35% of allograft loss. Chronic rejection is a complex clinical condition that includes both immunologic and non-immunologic causes and is more accurately referred to as Chronic Allograft Nephropathy (CAN). Although Calcineurin inhibitors (CNI) have played a central role in reducing acute rejection and improving allograft survival, it has long been shown that they contribute to interstitial fibrosis and chronic allograft nephropathy. Recent trials in adult transplantation have demonstrated that with the use of the TOR-inhibitor, Sirolimus, it is possible to withdraw Calcineurin inhibitors with no increase in rejection and with improvements in allograft function, interstitial fibrosis and long term survival (1). We hypothesize that the use of Sirolimus (SRL) in pediatric kidney transplantation will allow the withdrawal of Calcineurin inhibitor and improved kidney function and long term survival. We plan to enroll 50 patients at the time of transplantation. Patients will receive routine immunosuppression of CNI (Prograf), Mycophenolate mofetil (Cellcept) and prednisone. Those patients with normal function and no rejection episodes after 6 months of transplantation will undergo a slow conversion from Prograf to Sirolimus (Rapamune). We will then assess the rate of rejection, allograft function, fibrosis on biopsy, and allograft survival over the following 18 months.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Renal Transplant
Intervention  ICMJE Drug: Sirolimus
  1. Tacrolimus (Prograf®) At 6 months post-transplantation, patients will have Prograf® tapered by 25% per week such that they will be off of this medication by 7 months post-transplantation.
  2. Sirolimus (Rapamune®):

At 6 months post-transplantation, all patients will be administered Sirolimus at a dose of 1.65-2.79 mg/m2/day as a tablet or liquid (administered q 12 hours).

Other Names:
  • Rapamune
  • Rapamycin
Study Arms  ICMJE Sirolimus
Single arm
Intervention: Drug: Sirolimus
Publications * Not Provided

*   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: February 22, 2013)
52
Original Estimated Enrollment  ICMJE
 (submitted: November 6, 2007)
50
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria at Transplant:

  • Age < 19 years (up to the day of the 19th birthday)
  • Panel Reactive Antibody Level (PRA) <20% (Flow cytometry method)
  • Recipient of first living donor or deceased donor renal transplantation
  • Signed and dated informed consent (per local IRB standards)

Exclusion Criteria at Transplant:

  • Recipients of multi-organ transplants (e.g. kidney/pancreas transplant, etc.)
  • Peak PRA > 20% at any time
  • Recipient of en-bloc kidneys
  • Recipient of an organ from an HLA identical donor or a non-heart beating donor
  • Pregnant or lactating
  • Positive for HIV or an immunodeficiency virus
  • History of malignancy
  • Use of investigational agents within 4 weeks prior to transplantation
  • Current use of terfenadine, cisapride, astemizole, or pimozide (unless discontinued before administration of SRL)
  • Known hypersensitivity to sirolimus
  • Known hypersensitivity to Prograf, Cellcept, prednisone, Cremophor, HCO-60, or murine products
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE up to 19 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 NCT00555373
Other Study ID Numbers  ICMJE WIRB Pr. No.: 20101428
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mark Benfield, MD, Pediatric Nephrology of Alabama
Study Sponsor  ICMJE Pediatric Nephrology of Alabama
Collaborators  ICMJE
  • Pfizer
  • The Emmes Company, LLC
Investigators  ICMJE
Principal Investigator:Mark Benfield, M.D.Pediatric Nephrology of Alabama
PRS Account Pediatric Nephrology of Alabama
Verification Date February 2013

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