Heart TransplantationNCT00359658
Withdrawal of Steroids, Cyclosporine A Dose Reduction and Switch to Mycophenolatmofetile After Heart Transplantation
A study testing prednisolon, Mycophenolatmofetile and Cyclosporin A in people with Heart Transplantation, run by Hannover Medical School at 1 site in Germany.
Trial summary
The purpose of this study is first to improve or save renal function and second to decrease cardiac risk factors by optimising the immunosuppressive regimen by withdrawing steroids and reducing the Cyclosporine A dose. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Transplantation
- What is being tested?
- prednisolon, Mycophenolatmofetile and Cyclosporin A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2004to Jun 2008
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current immunosuppressive regimen: Cyclosporine A and corticosteroids for at least six month
- Heart transplantation above 3 years dated back
- Serum creatinine < 3,5 mg/dl (310 µmol/l) and BUN < 150 mg/dl
- Cyclosporine A blood level between 50 and 250 ng/ml during the last 12 month
Who cannot join
- Carcinoma within the last 3 years
- Acute rejection episodes during the last 6 month
- Infection requiring therapeutic intervention
- Hepatitis B, Hepatitis C or HIV infection
- WBC < 3000/µl, haemoglobin < 9g/dl, platelets < 70.000/µl
- Florid gastrointestinal ulcer
Show all 10Show fewer
- Haemodialysis within the last 4 weeks before study entry
- Pregnancy / lactation
- Administration of other immunosuppressive agents than prescribed
- Mycophenolatmofetile incompatibility
Trial locations and contacts
1 site in 1 country.
Germany1 site
Hannover Medical School, Department of Thoracic and Cardiovascular Surgery
Hanover, 30625
About this study
Official title: Conversion Study to Optimize Immunosuppressive Regimen by Withdrawal of Steroids, Cyclosporine A Dose Reduction and a Switch to Mycophenolatmofetile for Patients After Heart Transplantation in the Long-Term.
The purpose of this study is first to improve or save renal function and second to decrease cardiac risk factors by optimising the immunosuppressive regimen by withdrawing steroids and reducing the Cyclosporine A dose. The concomitant administration of Mycophenolatmofetile, an effective immunosuppressive agent, will minimize the risk of acute rejection episodes.
Read the detailed description
The decrease of quality of life in patients after heart transplantation in the long-term is determined by an increasing incidence of transplant vasculopathy and by immunosuppression-related side effects. Calcineurin inhibitors are associated with chronic nephrotoxicity, while long-term administration of steroids results in an increased incidence of cardiovascular risk factors (e.g. hypertension, lipometabolic disorders, steroid induced diabetes, adipositas)and therefore, carries the potential of graft disfunction.
- Conditions
- Heart Transplantation
- Being tested
- prednisolon, Mycophenolatmofetile, Cyclosporin A
- Keywords
- Cyclosporine, Glucocorticoids, renal insufficiency, chronic, long-term care
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prednisolonDrug
Also called Decortin, steroid withdrawal
prednisolon withdrawal: reduction of maintenance dosage, 0,5 mg of the daily dose every week till withdrawal
MycophenolatmofetileDrug
Also called MMF, Cellcept
Mycophenolatmofetile administration: start doses 250 mg, increase of the daily dose about 250 mg every week till reaching 2 g/daily
Cyclosporin ADrug
Also called Sandimmun optoral
Cyclosporin A reduction: 8 weeks after starting prednisolon withdrawal and Mycophenolatmofetile administration reduction of Cyclosporin A trough level till a range from 50 to 90 ng/ml
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | prednisolon withdrawal: reduction of maintenance dosage, 0,5 mg of the daily dose every week till withdrawal; Mycophenolatmofetile administration: start doses 250 mg, increase of the daily dose about 250 mg every week till reaching 2 g/daily; Cyclosporin A reduction: 8 weeks after starting prednisolon withdrawal and Mycophenolatmofetile administration reduction of Cyclosporin A trough level till a range from 50 to 90 mg/ml Receives: Drug: prednisolon; Drug: Mycophenolatmofetile; Drug: Cyclosporin A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal function evaluated by serum creatinine at month 12 and month 24
Measured: month 12 and month 24
Secondary outcomes (3)
Cardiovascular risk factors at month 12 and month 24
Measured: month 12 and month 24
Acute rejection episodes, gastrointestinal disorders and other adverse events at month 12 and month 24
Measured: month 12 and month 24
Quality of life assessed by the SF36, spiroergometry, concomitant medication at month 12 and month 24
Measured: month 12 and month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2006 (estimated)
- Study startNov 2004
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart TransplantationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Investigators
- Christoph Bara, Dr. med., Study director, Hannover Medical School, Department of Thoracic and Cardiovascular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00359658
- Sponsor's protocol ID
- KKS-94/2004
- Status last verified
- Feb 2009
- First submitted
- 1 Aug 2006
- Last updated
- 13 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Faulhaber M, Mading I, Malehsa D, Raggi MC, Haverich A, Bara CL. Steroid withdrawal and reduction of cyclosporine A under mycophenolate mofetil after heart transplantation. Int Immunopharmacol. 2013 Apr;15(4):712-7. doi: 10.1016/j.intimp.2013.02.012. Epub 2013 Feb 28.
PubMed 23454241
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conversion Study to Optimize Immunosuppressive Regimen by Withdrawal of Steroids, Cyclosporine A Dose Reduction and a Switch to Mycophenolatmofetile for Patients After Heart Transplantation in the Long-Term.
- ClinicalTrials.gov ID
- NCT00359658
- Acronym / sponsor ID
- KKS-94/2004
- Conditions
- Heart Transplantation
- Keywords
- Cyclosporine, Glucocorticoids, renal insufficiency, chronic, long-term care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- Nov 2004
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 2 Aug 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 first to improve or save renal function and second to decrease cardiac risk factors by optimising the immunosuppressive regimen by withdrawing steroids and reducing the Cyclosporine A dose. The concomitant administration of Mycophenolatmofetile, an effective immunosuppressive agent, will minimize the risk of acute rejection episodes.
Detailed description
The decrease of quality of life in patients after heart transplantation in the long-term is determined by an increasing incidence of transplant vasculopathy and by immunosuppression-related side effects. Calcineurin inhibitors are associated with chronic nephrotoxicity, while long-term administration of steroids results in an increased incidence of cardiovascular risk factors (e.g. hypertension, lipometabolic disorders, steroid induced diabetes, adipositas)and therefore, carries the potential of graft disfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: prednisolon, Drug: Mycophenolatmofetile, Drug: Cyclosporin Aprednisolon withdrawal: reduction of maintenance dosage, 0,5 mg of the daily dose every week till withdrawal; Mycophenolatmofetile administration: start doses 250 mg, increase of the daily dose about 250 mg every week till reaching 2 g/daily; Cyclosporin A reduction: 8 weeks after starting prednisolon withdrawal and Mycophenolatmofetile administration reduction of Cyclosporin A trough level till a range from 50 to 90 mg/ml |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Current immunosuppressive regimen: Cyclosporine A and corticosteroids for at least six month
- Heart transplantation above 3 years dated back
- Serum creatinine < 3,5 mg/dl (310 µmol/l) and BUN < 150 mg/dl
- Cyclosporine A blood level between 50 and 250 ng/ml during the last 12 month
Key exclusion criteria (10 listed)
- Carcinoma within the last 3 years
- Acute rejection episodes during the last 6 month
- Infection requiring therapeutic intervention
- Hepatitis B, Hepatitis C or HIV infection
- WBC < 3000/µl, haemoglobin < 9g/dl, platelets < 70.000/µl
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 |
|---|---|---|
| prednisolonAlso: Decortin, steroid withdrawalprednisolon withdrawal: reduction of maintenance dosage, 0,5 mg of the daily dose every week till withdrawal | Drug | 1 |
| MycophenolatmofetileAlso: MMF, CellceptMycophenolatmofetile administration: start doses 250 mg, increase of the daily dose about 250 mg every week till reaching 2 g/daily | Drug | 1 |
| Cyclosporin AAlso: Sandimmun optoralCyclosporin A reduction: 8 weeks after starting prednisolon withdrawal and Mycophenolatmofetile administration reduction of Cyclosporin A trough level till a range from 50 to 90 ng/ml | Drug | 1 |
Primary outcome
Renal function evaluated by serum creatinine at month 12 and month 24
Time frame: month 12 and month 24
3 secondary outcomes
Cardiovascular risk factors at month 12 and month 24
Time frame: month 12 and month 24
Acute rejection episodes, gastrointestinal disorders and other adverse events at month 12 and month 24
Time frame: month 12 and month 24
Quality of life assessed by the SF36, spiroergometry, concomitant medication at month 12 and month 24
Time frame: month 12 and month 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2009.
- Derived from this study: PubMed 23454241Faulhaber M, Mading I, Malehsa D, Raggi MC, Haverich A, Bara CL. Steroid withdrawal and reduction of cyclosporine A under mycophenolate mofetil after heart transplantation. Int Immunopharmacol. 2013 Apr;15(4):712-7. doi: 10.1016/j.intimp.2013.02.012. Epub 2013 Feb 28.
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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.
Christoph Bara, Dr. med. study director
Hannover Medical School, Department of Thoracic and Cardiovascular Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prednisolon, Mycophenolatmofetile and Cyclosporin A in people with Heart Transplantation, run by Hannover Medical School at 1 site in Germany.
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 4 inclusion and 10 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: finished, as of the sponsor's last update on 13 Feb 2009. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Renal function evaluated by serum creatinine at month 12 and month 24 (time frame: month 12 and month 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00359658, which also lists 1 linked publication.
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 13 Feb 2009.