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

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ClinicalTrials.gov Identifier: NCT00273559
Recruitment Status : Unknown
Verified November 2007 by Florida Hospital Transplant Center.
Recruitment status was:  Active, not recruiting
First Posted : January 9, 2006
Last Update Posted : May 12, 2008
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Kidney Diseases Drug: prednisone Phase 4

Detailed Description:

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 These studies show that many patients can safely have steroids withdrawn with equivalent results whan compared to those who remain on steroids.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.


Study Design

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Single Center, Open Label, Comparative, Controlled Trial to Assess the Risks and Benefits of Steroid Elimination vs. Steroid Therapy After Renal Transplantation
Study Start Date : January 2006
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Prednisone
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
1
subjects who remain on steroids after discharge
2
Subjects will be off steroids at the time of discharge
Drug: prednisone
group 2 will remain on 5 mg of prednisone for at least 90 days post transplant.


Outcome Measures

Primary Outcome Measures :
  1. Acute rejection [ Time Frame: 6 months ]
  2. Patient and graft survival [ Time Frame: 6 months ]
  3. Incidence of infection [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Quality of life (health survey) [ Time Frame: one year ]
  2. Incidence of post-transplant diabetes [ Time Frame: one year ]
  3. Incidence of osteopenia/osteoporosis at baseline and one year [ Time Frame: one year ]
  4. Renal function [ Time Frame: one year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
de novo renal transplant recipients
Criteria

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
Contacts and Locations

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): NCT00273559


Locations
United States, Florida
Florida Hospital Transplant Center
Orlando, Florida, United States, 32804
Sponsors and Collaborators
Florida Hospital Transplant Center
Genzyme, a Sanofi Company
Novartis
Investigators
Principal Investigator: Michael Angelis, MD Florida Hospital Transplant Center
More Information

Responsible Party: Michael Angelis, MD, Florida Hospital Transplant Center
ClinicalTrials.gov Identifier: NCT00273559     History of Changes
Other Study ID Numbers: TL092005-1
First Posted: January 9, 2006    Key Record Dates
Last Update Posted: May 12, 2008
Last Verified: November 2007

Keywords provided by Florida Hospital Transplant Center:
Renal Transplantation

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases
Prednisone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents