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Pilot Study for HLA Identical Living Donor Renal Transplant Recipients

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ClinicalTrials.gov Identifier: NCT00352092
Recruitment Status : Completed
First Posted : July 14, 2006
Last Update Posted : November 13, 2014
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Rita Alloway, University of Cincinnati

Brief Summary:
The purpose of this study is to evaluate the safety and effectiveness of a steroid-free and calcineurin-inhibitor free treatment regimen for patients who are receiving a kidney transplant from a living donor that is HLA-identical (has a similar immune system).

Condition or disease Intervention/treatment Phase
Renal Transplant Drug: calcineurin inhibitor Drug: sirolimus Drug: mycophenolate mofetil Phase 4

Detailed Description:

The purpose of this study is to evaluate the safety and effectiveness of a steroid-free and calcineurin-inhibitor free treatment regimen for patients who are receiving a kidney transplant from a living donor that is HLA - identical, or in other words, has a similar immune system. The immune system is a defense system that the body uses to fight foreign substances that enter the body, such as a transplanted kidney. Two people with similar immune systems are less likely to fight off or reject an organ donated from one to the other. HLA-identical kidney transplant recipients are less likely to need large amounts of immunosuppression because they are immunologically similar. In this study, you will be treated with the immunosuppressive medications, Cellcept, Rapamune, and Prograf and after a rejection free period will remain on Cellcept alone. This treatment regimen is currently being used at The University of Cincinnati for all HLA-identical living donor kidney transplant recipients. This study is being conducted to determine if the protocol currently being used results in beneficial outcomes for HLA-identical kidney transplant recipients.

Only recently have transplant centers considered avoiding steroid therapy (prednisone) in any transplant patient because steroids have been used successfully for so long, but with many side effects. The ability to stop steroids has occurred due to the availability of newer more effective immunosuppressive medications. Stopping steroids has been tried in patients who are considered to be at both low and higher risk of kidney rejection. Patients considered at risk for rejection may typically be left on steroids forever or no attempts to stop the steroids would be made until the patient is one year after transplant and has already received a lot of steroid therapy resulting in side effects. This study will be conducted in patients that are low risk for rejection and can potentially benefit from steroid avoidance.

Overall, the concept of steroid avoidance in patients that are at low risk for rejection is now much more acceptable because newer, more potent medications have recently become available to prevent acute rejection. These newer medications include Prograf (tacrolimus), Cellcept (mycophenolate mofetil), and Rapamune (sirolimus). Currently, most kidney transplant recipients receive medications consisting of tacrolimus or cyclosporine, mycophenolate mofetil or azathioprine, and steroids. However, recently, the combination of Prograf (tacrolimus) and Rapamune (sirolimus) with steroid withdrawal 3 months after transplantation was studied in patients receiving liver, liver/kidney, and kidney/pancreas transplants. This study showed a low rate of acute rejection with excellent patient and kidney survival.

The addition of Cellcept to Prograf and Rapamune is thought to be a safe and effective alternative to the use of steroids in transplant patients. Due to the low risk of rejection for HLA-identical kidney transplant recipients, patients in this study will be slowly withdrawn from both Rapamune and Prograf over a rejection free period of time. Withdrawal of these medications and avoidance of steroids could decrease the development of high blood pressure, high cholesterol, diabetes, tremors, and infection after transplant. This study will determine if this medication regimen is safe, effective, and able to produce beneficial post transplant outcomes.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Corticosteroid-Free, Calcineurin-Sparing Immunosuppression Protocol for HLA-Identical Living Donor Renal Transplant Recipient
Study Start Date : June 2002
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Incidence of biopsy confirmed acute rejection at 12 and 24 months.

Secondary Outcome Measures :
  1. Patient survival
  2. Graft survival
  3. Early discontinuation of mycophenolate mofetil, tacrolimus, or sirolimus due to toxicity
  4. Time to acute rejection from transplant
  5. Severity of acute rejection measure by Banff'93 criteria, and/or requirement of antilymphocyte treatment; need for corticosteroid pulse or maintenance therapy for rejection or recurrent disease
  6. Evaluation of 24-hour proteinuria at 24 months post-transplant
  7. Evaluation of graft function by calculated CrCl (Cockroft-Gault) at 1, 3, 6, 12, and 24 months post-transplant
  8. Patient weight
  9. Quantitative bone loss
  10. Cholesterol and triglyceride levels at 12 and 24 months
  11. Cardiovascular risk assessment by Framingham criteria at 0, 1, and 24 months


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 to 70 years
  • Male/female recipients
  • All ethnic groups
  • Negative pregnancy test
  • Practicing an acceptable form of birth control
  • Signing informed consent

Exclusion Criteria:

  • Known sensitivity or contraindication to mycophenolate mofetil, tacrolimus, or sirolimus
  • Re-transplants who lost primary transplant from immunologic causes (patients with graft loss secondary to technical or calcineurin-inhibitor toxicity will be included)
  • Liver, heart, pancreas or small bowel transplant recipient
  • Fasting total cholesterol >300 mg/dL and fasting triglycerides >400 mg/dL
  • Baseline WBC count <3000/cu.mm
  • Baseline platelet count <100,000/cu.mm
  • Known or suspected malignancy within previous 3 years, (Patients with squamous cell and basal skin cancer are not excluded)
  • Active systemic infection

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): NCT00352092


Locations
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United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Sponsors and Collaborators
University of Cincinnati
Roche Pharma AG
Investigators
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Principal Investigator: Rita Alloway, Pharm.D. University of Cincinnati

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Responsible Party: Rita Alloway, Research Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00352092     History of Changes
Other Study ID Numbers: CEL313
First Posted: July 14, 2006    Key Record Dates
Last Update Posted: November 13, 2014
Last Verified: November 2014
Keywords provided by Rita Alloway, University of Cincinnati:
Kidney disease
Renal transplant
HLA Identical
Living Donor
Corticosteroid free
Calcineurin sparing
Adults
Additional relevant MeSH terms:
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Sirolimus
Mycophenolic Acid
Calcineurin Inhibitors
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antitubercular
Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action