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Minneapolis, Minnesota 55455

  • Graft Rejection

Purpose:

Everolimus is an immunosuppressive drug that is being studied for preventing acute rejection that can happen after heart transplantation. It is usually used in combination with other immunosuppressive drugs such as cyclosporine. The purpose of this study is to evaluate the change in kidney function after beginning everolimus, while determining the most effective Neoral® (cyclosporine) dose to take with everolimus, in adult cardiac transplant patients who have had their transplanted heart for at least 1 year and who have cardiac allograft vasculopathy.


Criteria:

Inclusion Criteria: - Male or female adult with an established cardiac allograft vasculopathy defined as any new luminal irregularity on coronary angiography. - Patient must be on statins at study entry. - Patient who is more than 12 months post-transplant. Exclusion Criteria: - Patient with a serum creatinine value >2.0 mg/dL. - Patient with a biopsy-proven acute rejection episode (>= ISHLT 3A) within 6 months prior to study entry. - Patient who had received any investigational drug within 4 weeks prior to study entry.


Study is Available At:


Original ID:

CRAD001A2405


NCT ID:

NCT00097968


Secondary ID:

RAD/Certican


Study Acronym:


Brief Title:

Safety/Efficacy of Everolimus and Neoral® in Adult Cardiac Transplant Patients With Established Allograft Vasculopathy


Official Title:

An Open-Label, Single Arm, Pilot Study of the Renal Safety of Everolimus in Addition to Neoral® in Cardiac Transplant Recipients With Established Allograft Vasculopathy


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Novartis


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Overall Contact Information

Official Name:Richard Dorent, MD
Study Director
Novartis Pharmaceuticals

Study Dates

Start Date:August 2004
Primary Completion Date:April 2005
Primary Completion Type:Actual
Verification Date:July 2010
Last Changed Date:July 9, 2010
First Received Date:December 1, 2004

Study Outcomes

Outcome Type:Primary Outcome
Measure:Change in renal function at 6 assessed by comparing serum creatinine levels at 6 months to baseline values.
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Major Adverse Cardiac Events at 3 and 6 months.
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Patient survival at 3 and 6 months.
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Treated acute rejection at 3 and 6 months.
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Admission to the hospital at 3 and 6 months.
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Premature study treatment discontinuation at 3 and 6 months.
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:everolimus

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Novartis Pharmaceuticals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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