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

• ClinicalTrials.gov Identifier: NCT00273559
• Recruitment Status: Unknown
• First Posted: January 9, 2006
• Last Update Posted: May 12, 2008
• Sponsor: Florida Hospital Transplant Center
• Collaborators: Genzyme, a Sanofi Company; Novartis
• Information provided by: Florida Hospital Transplant Center

Tracking Information

• First Submitted Date: January 5, 2006
• First Posted Date: January 9, 2006
• Last Update Posted Date: May 12, 2008
• Study Start Date: January 2006
• Primary Completion Date: Not Provided

Current Primary Outcome Measures (submitted: November 14, 2007)

• Acute rejection [ Time Frame: 6 months ]
• Patient and graft survival [ Time Frame: 6 months ]
• Incidence of infection [ Time Frame: one year ]

• Original Primary Outcome Measures: Not Provided

Current Secondary Outcome Measures (submitted: November 14, 2007)

• Quality of life (health survey) [ Time Frame: one year ]
• Incidence of post-transplant diabetes [ Time Frame: one year ]
• Incidence of osteopenia/osteoporosis at baseline and one year [ Time Frame: one year ]
• Renal function [ Time Frame: one year ]

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study Comparing Outcomes of Kidney Transplants in Patients on Steroids Versus Those Who Discontinue Steroids
• 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
• 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.

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 These studies show that many patients can safely have steroids withdrawn with equivalent results whan compared to those who remain on steroids.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 Type: Observational
• Study Design: Observational Model: Case-Control; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: de novo renal transplant recipients
• Condition: Kidney Diseases

Intervention

Drug: prednisone

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

Study Groups/Cohorts

• 1
  subjects who remain on steroids after discharge
• 2
  Subjects will be off steroids at the time of discharge
  Intervention: Drug: prednisone

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: January 5, 2006): 60
• Original Enrollment: Same as current
• Estimated Study Completion Date: December 2008
• Primary Completion Date: Not Provided

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00273559
• Other Study ID Numbers: TL092005-1
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Michael Angelis, MD, Florida Hospital Transplant Center
• Original Responsible Party: Not Provided
• Current Study Sponsor: Florida Hospital Transplant Center
• Original Study Sponsor: Same as current

Collaborators

• Genzyme, a Sanofi Company
• Novartis

Investigators

• Principal Investigator: Michael Angelis, MD; Florida Hospital Transplant Center

• PRS Account: Florida Hospital Transplant Center
• Verification Date: November 2007