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A Study Comparing Outcomes of Kidney Transplants in Patients on Steroids Versus Those Who Discontinue Steroids

NCT ID: NCT00273559

Last Updated: 2008-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-12-31

Brief Summary

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The purpose of this study is to compare the risks and benefits of steroid elimination versus steroid therapy in renal transplant patients particularly looking at the effects on bone mass, lipids, hypertension, and new onset diabetes.

Detailed Description

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The use of steroids after renal transplantation has been invaluable, resulting in higher rates of long term survival of the transplanted kidney. However, post-operative steroids are also associated with frequent post-operative and long term complications. There have been steroid elimination studies analyzing acute rejection rates, graft and patient survival. These studies show that many patients can safely have steroids withdrawn with equivalent results whan compared to those who remain on steroids.

With this study we will be using a rapid steroid elimination protocol for 40 patients and compare 20 patients who remain on steroids. We hope to show a decreased rate of complications such as osteopenia/osteoporosis, new onset diabetes, and a decrease in cardiovascular risk factors such as hyperlipidemia and hypertension.

Solumedrol will be given to all patients at the time of transplant followed by a prednisone taper. Those remaining on steroids will be discharged on prednisone 5 mg daily. Those in whom steroids are eliminated will be off prednisone by discharge.

Conditions

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Kidney Diseases

Keywords

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Renal Transplantation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1

subjects who remain on steroids after discharge

No interventions assigned to this group

2

Subjects will be off steroids at the time of discharge

prednisone

Intervention Type DRUG

group 2 will remain on 5 mg of prednisone for at least 90 days post transplant.

Interventions

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prednisone

group 2 will remain on 5 mg of prednisone for at least 90 days post transplant.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing a single renal transplant from deceased or living donor
* Adults 18 years and older
* First or second renal transplant
* Capable of understanding the purposes of the study, has given written informed consent, and agrees to comply with the study requirements
* Women of child bearing age should have a negative serum pregnancy test

Exclusion Criteria

* Greater than 2 renal transplants
* Age \< 18 years
* Patients receiving immunosuppressive therapy within the preceding 28 days for first transplant and 3 months for the second transplant
* Cold ischemia time \> 30 hours
* History of malignancy in the last 5 years except successfully treated localized non-melanoma skin cancer
* HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV) positive serology
* Loss of previous transplant in \< 1 year
* History of non-compliance
* Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may impair communication with the investigator or compliance with study procedures
* Multiple organ transplant
* History of chronic steroid use except for inhaled steroids for asthma
* Pregnant or lactating females
* Women of childbearing potential not willing to use a reliable form of contraception.
* Patients with severe medical condition(s) that, in the view of the investigator, prohibits participation in the study
* Known sensitivity to study drugs or class of study drugs
* Use of any investigational agent in the last 30 days
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role collaborator

Novartis

INDUSTRY

Sponsor Role collaborator

Florida Hospital Transplant Center

OTHER

Sponsor Role lead

Responsible Party

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Florida Hospital Transplant Center

Principal Investigators

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Michael Angelis, MD

Role: PRINCIPAL_INVESTIGATOR

Florida Hospital Transplant Center

Locations

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Florida Hospital Transplant Center

Orlando, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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TL092005-1

Identifier Type: -

Identifier Source: org_study_id