Kidney DiseasesNCT00273559
A Study Comparing Outcomes of Kidney Transplants in Patients on Steroids Versus Those Who Discontinue Steroids
An observational study of Kidney Diseases, run by Florida Hospital Transplant Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Diseases
- What is being tested?
- prednisone
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Dec 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: de novo renal transplant recipients
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida Hospital Transplant Center
Orlando, Florida, 32804
About this study
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
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.
Read the 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.
- Conditions
- Kidney Diseases
- Being tested
- prednisone
- Keywords
- Renal Transplantation
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prednisoneDrug
group 2 will remain on 5 mg of prednisone for at least 90 days post transplant.
| Study group | Role | What they receive |
|---|---|---|
| 1 | subjects who remain on steroids after discharge | |
| 2 | Subjects will be off steroids at the time of discharge Receives: Drug: prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute rejection
Measured: 6 months
Patient and graft survival
Measured: 6 months
Incidence of infection
Measured: one year
Secondary outcomes (4)
Quality of life (health survey)
Measured: one year
Incidence of post-transplant diabetes
Measured: one year
Incidence of osteopenia/osteoporosis at baseline and one year
Measured: one year
Renal function
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2006 (estimated)
- Study startJan 2006
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida Hospital Transplant Center
- Sponsor type
- University, hospital or other
- Collaborators
- Genzyme, a Sanofi Company, Novartis
- Investigators
- Michael Angelis, MD, Principal investigator, Florida Hospital Transplant Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00273559
- Sponsor's protocol ID
- TL092005-1
- Status last verified
- Nov 2007
- First submitted
- 5 Jan 2006
- Last updated
- 12 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00273559
- Acronym / sponsor ID
- TL092005-1
- Conditions
- Kidney Diseases
- Keywords
- Renal Transplantation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Florida Hospital Transplant CenterUniversity, hospital or other
- Collaborators
- Genzyme, a Sanofi Company, Novartis
- Study start
- Jan 2006
- Study completion
- Dec 2008 (estimated)
- First posted
- 9 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –subjects who remain on steroids after discharge |
| 2 | – | Drug: prednisoneSubjects will be off steroids at the time of discharge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- de novo renal transplant recipients
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prednisonegroup 2 will remain on 5 mg of prednisone for at least 90 days post transplant. | Drug | 2 |
Primary outcome
Acute rejection
Time frame: 6 months
Patient and graft survival
Time frame: 6 months
Incidence of infection
Time frame: one year
4 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2008.
Related trials for Kidney Diseases
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Angelis, MD principal investigator
Florida Hospital Transplant Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Diseases, run by Florida Hospital Transplant Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute rejection (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2008.