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Comparing Everolimus and Sirolimus in Renal Transplant Recipients

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ClinicalTrials.gov Identifier: NCT01976390
Recruitment Status : Unknown
Verified May 2017 by Dr.Ronald Pelletier, Ohio State University.
Recruitment status was:  Active, not recruiting
First Posted : November 5, 2013
Last Update Posted : May 11, 2017
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Dr.Ronald Pelletier, Ohio State University

Brief Summary:
This study is being done to compare the effectiveness and safety of two different kidney transplant immunosuppression drugs, Zortress (the study drug) and Rapamune (which is used in the current standard immunosuppression regimen).

Condition or disease Intervention/treatment Phase
Renal Failure Drug: Everolimus Drug: Sirolimus Not Applicable

Detailed Description:
Zortress is FDA approved, is used as standard of care at some other institutions, and may also be given as standard of care if it is believed to be the best immunosuppression regimen for a particular kidney transplant recipient. The rationale for testing Zortress vs. Rapamune is to determine which of these drugs is more effective in preventing chronic rejection of the transplanted kidney. Because these two drugs are related to each other there is no current literature addressing the replacement of Rapamune with Zortress in an immunosuppression regimen, therefore the goal of this study is to compare these two immunosuppression drugs.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Prospective, Randomized, Single Center Pilot Study Comparing Patient and Graft Survival, Adverse Events and Tolerability of Zortress® (Everolimus) Versus Rapamune® (Sirolimus) in Combination With Low Dose Neoral® (Cyclosporine) Dosed by C2 Monitoring, in Deceased and Living Donor Renal Transplant Recipients Under a Thymoglobulin® (Antithymocyte Globulin) and Rapid Steroid Induction Protocol.
Study Start Date : February 2014
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Zortress (Everolimus)
Zortress will be started on day of transplant and initially dosed at 0.75 mg twice a day (12 hours apart) dosed simultaneously with Neoral.
Drug: Everolimus
0.75mg twice a day, Orally, starting on day of transplant
Other Name: Zortress

Active Comparator: Rapamune (Sirolimus)
Rapamune will be dosed on day of transplant at 5 mg/d, decreasing to 3 mg/d.
Drug: Sirolimus
5mg, Orally, starting on day of transplant; decreasing to 3mg
Other Name: Rapamune




Primary Outcome Measures :
  1. Graft Survival Comparison of Zortress vs. Rapamune [ Time Frame: 1 Year ]
    The primary objective of this pilot study will be to determine equivalency of Zortress® as compared to Rapamune® when used in our de novo immunosuppression regimen following renal transplantation. The primary endpoint will be a composite endpoint of graft survival (non-death censored) and biopsy proven acute rejection at 1 year. The primary outcome of immunosuppressive protection would be studied in our Thymoglobulin and rapid steroid discontinuation protocol, with "half-dose" Neoral as described above.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must give written informed consent before any assessment is performed.
  2. Primary renal transplant recipients between ages 18 and 75 years of age.
  3. Females capable of becoming pregnant must have a negative pregnancy test prior to transplantation and practice an effective form of birth control for the duration of the study and 12 weeks after discontinuation of the study drug if applicable.

Exclusion Criteria:

  1. Total cholesterol > 300 mg/dl or triglycerides > 400 mg/dl despite lipid lowering therapy
  2. Pre-existing bone marrow suppression (White Blood Cell count of < 3000, platelets < 100,000)
  3. Active infection (Hepatitis B Virus, HIV)
  4. Malignancy (except for adequately treated squamous or basal cell skin carcinoma) unless patient has written clearance from an Oncologist or if patient has had no malignancy for at least 2 years prior to the transplant
  5. Allergy or intolerance to Zortress, Rapamune, cyclosporine, or Anti-thymocyte globulin

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): NCT01976390


Locations
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United States, Ohio
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43212
Sponsors and Collaborators
Dr.Ronald Pelletier
Novartis
Investigators
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Principal Investigator: Ronald Pelletier, MD OSU Wexner Medical Center

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Responsible Party: Dr.Ronald Pelletier, Principal Investigator, Ohio State University
ClinicalTrials.gov Identifier: NCT01976390    
Other Study ID Numbers: 2013H0229
First Posted: November 5, 2013    Key Record Dates
Last Update Posted: May 11, 2017
Last Verified: May 2017
Keywords provided by Dr.Ronald Pelletier, Ohio State University:
Kidney
Kidney transplant
Renal failure
End Stage Renal Disease
kidney transplant recipient
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases
Sirolimus
Everolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents