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

NCT00273559 | Unknown DMC

• 1 other identifier: TL092005-1
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Diseases

Keywords

Renal Transplantation

Outcome Measures

Primary Outcomes (3)

• Acute rejection

  6 months

• Patient and graft survival

  6 months

• Incidence of infection

  one year

Secondary Outcomes (4)

• Quality of life (health survey)

  one year

• Incidence of post-transplant diabetes

  one year

• Incidence of osteopenia/osteoporosis at baseline and one year

  one year

• Renal function

  one year

Study Arms (2)

1

subjects who remain on steroids after discharge

2

Subjects will be off steroids at the time of discharge

Drug: prednisone

Interventions

prednisone DRUG

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

de novo renal transplant recipients

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Florida Hospital Transplant Center: lead
• Genzyme, a Sanofi Company: collaborator
• Novartis: collaborator

Study Sites (1)

Florida Hospital Transplant Center

Orlando, Florida, 32804, United States

Location

MeSH Terms

Conditions

Kidney Diseases

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Michael Angelis, MD

  Florida Hospital Transplant Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 5, 2006
• First Posted: January 9, 2006
• Study Start: January 1, 2006
• Study Completion: December 1, 2008
• Last Updated: May 12, 2008

Record last verified: 2007-11

Locations

US (1)