CYCLOSPORINE/TACROLIMUSPhase 4NCT02496494
The Effects of Conversion From Cyclosporine to Tacrolimus on the Changes of Cardiovascular Risk Profiles and Serum Metabolites in Renal Transplant Recipients
A Phase 4 study testing Tacrolimus in people with CYCLOSPORINE/TACROLIMUS, run by Kyungpook National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the effects of conversion from cyclosporine to tacrolimus on the changes of cardiovascular risk profiles and serum metabolites in renal transplant recipients. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- CYCLOSPORINE/TACROLIMUS
- What is being tested?
- Tacrolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2012to Dec 2015
- Phase
- Phase 4
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who received a kidney transplant at least 12 months ago prior to enrollment
- Patients who have kept in unchanged cyclosporine therapy at least for 6 months prior to enrollment.
- Female patients of childbearing potential must have a negative urine or serum pregnancy test prior to enrollment, and agreed to the deliberate prevention of conception during the trial
- Patients who are considered clinically stable by observer's judgment.
- Patients must understand the purpose and risk of participating the the trial and signed on the written consent.
Who cannot join
- Patients who have previously received an organ transplant other than a kidney
- Patients diagnosed with congestive heart failure within 6 months (EF <35%)
- Patients with untreated ischemic heart disease
- Patients whose hemoglobin is in the level of <7.0 g/dL
- Patients who have a known hypersensitivity to tacrolimus
- Patients taking potassium sparing diuretics
Show all 9Show fewer
- Patients newly diagnosed malignant tumors after organ transplant but the patients treated completely with basal or squamous cell carcinoma of the skin are excepted
- Patients who are at the risk of drug abuse or mental disorders or communicate difficulties with the observer
- Patients who are pregnant or lactating
Trial locations and contacts
1 site in 1 country.
Chan-Duck Kim, M.D., PhD contact
South Korea1 site, 1 recruiting
- Recruiting
Kyungpook National University Hospital
Daegu
Chan-Duck Kim, drcdkim@knu.ac.kr
About this study
The purpose of this study is to evaluate the effects of conversion from cyclosporine to tacrolimus on the changes of cardiovascular risk profiles and serum metabolites in renal transplant recipients.
Read the detailed description
During the past two decades, cyclosporine has proved to be a valuable immunosuppressive drug that has contributed to a significant reduction in the incidence of acute rejection after kidney transplantation. However, cyclosporine is known as a major factor causing cardiovascular death in kidney transplant recipients. Moreover, cyclosporine has an adverse effect on the lipid profile and fibrinolytic system and result in hypertension and cardiovascular disease. Immunosupressive mechanism of tacrolimus is identical that of cyclosporine but it is 100 times more potent T cell inhibitor than cyclosporine. In multicenter study of Europe and United states, tacrolimus showed low incidence of acute rejection and was known to effective in acute rejection resistant to other therapy. Tacrolimus has a lot of advantages compared to cyclosporine in terms of hypertensive and hyperlipidemic effects although evidences are lacking. One study demonstrated cardiovascular risk profile and renal function has been improved in kidney transplant patients after randomized conversion from cyclosporine to tacrolimus Previous study analyzing metabolites of tacrolimus and cyclosporine revealed that differences were observed in the metabolite level of hypoxanthine, lactate, succinate, and taurine between two immunosupressants. The objective of this study is to evaluate changes in cardiovascular risk profiles and metabolite patterns after conversion from cyclosporine to tacrolimus in kidney transplant recipients.
- Conditions
- CYCLOSPORINE/TACROLIMUS
- Being tested
- Tacrolimus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TacrolimusDrug
Also called TacroBell
Tacrolimus for maintenance immunosupression in kidney transplant recipients
| Study group | Role | What they receive |
|---|---|---|
| Tacrolimus conversion group | Experimental | Cyclosprine was converted to tacrolimus in kidney transplant recipients. Receives: Drug: Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Blood Pressure at 6 months
Measured: 3 months, 6 months
Change from Baseline in Lipid Profile at 6 months
Measured: 3 months, 6 months
Secondary outcomes (4)
Assessing glucose regulation using blood glucose and hemoglobin A1c
Measured: 3 months, 6 months
Assessing other metabolic cardiovascular risk factors using fibrinogen, tPA, PAI-I, homocysteine, pro-BNP, hs-CRP, uric acid
Measured: 24 weeks
Assessing serum metabolite using ELISA
Measured: 3 months, 6 months
Assessing renal function using blood urea nitrogen and creatinine
Measured: 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study startSep 2012
- Primary completionJul 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CYCLOSPORINE/TACROLIMUSStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chan-Duck Kim, M.D., Ph.D., Kyungpook National University Hospital
- Investigators
- Chan-Duck Kim, Principal investigator, Kyungpook National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02496494
- Sponsor's protocol ID
- KNUH 2012-09-010
- Status last verified
- Jul 2015
- First submitted
- 3 Jul 2015
- Last updated
- 14 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Conversion From Cyclosporine to Tacrolimus on the Changes of Cardiovascular Risk Profiles and Serum Metabolites in Renal Transplant Recipients
- ClinicalTrials.gov ID
- NCT02496494
- Acronym / sponsor ID
- KNUH 2012-09-010
- Conditions
- CYCLOSPORINE/TACROLIMUS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 14 Jul 2015 (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 evaluate the effects of conversion from cyclosporine to tacrolimus on the changes of cardiovascular risk profiles and serum metabolites in renal transplant recipients.
Detailed description
During the past two decades, cyclosporine has proved to be a valuable immunosuppressive drug that has contributed to a significant reduction in the incidence of acute rejection after kidney transplantation. However, cyclosporine is known as a major factor causing cardiovascular death in kidney transplant recipients. Moreover, cyclosporine has an adverse effect on the lipid profile and fibrinolytic system and result in hypertension and cardiovascular disease. Immunosupressive mechanism of tacrolimus is identical that of cyclosporine but it is 100 times more potent T cell inhibitor than cyclosporine. In multicenter study of Europe and United states, tacrolimus showed low incidence of acute rejection and was known to effective in acute rejection resistant to other therapy. Tacrolimus has a lot of advantages compared to cyclosporine in terms of hypertensive and hyperlipidemic effects although evidences are lacking. One study demonstrated cardiovascular risk profile and renal function has been improved in kidney transplant patients after randomized conversion from cyclosporine to tacrolimus Previous study analyzing metabolites of tacrolimus and cyclosporine revealed that differences were observed in the metabolite level of hypoxanthine, lactate, succinate, and taurine between two immunosupressants. The objective of this study is to evaluate changes in cardiovascular risk profiles and metabolite patterns after conversion from cyclosporine to tacrolimus in kidney transplant recipients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tacrolimus conversion group | Experimental | Drug: TacrolimusCyclosprine was converted to tacrolimus in kidney transplant recipients. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who received a kidney transplant at least 12 months ago prior to enrollment
- Patients who have kept in unchanged cyclosporine therapy at least for 6 months prior to enrollment.
- Female patients of childbearing potential must have a negative urine or serum pregnancy test prior to enrollment, and agreed to the deliberate prevention of conception during the trial
- Patients who are considered clinically stable by observer's judgment.
- Patients must understand the purpose and risk of participating the the trial and signed on the written consent.
Key exclusion criteria (9 listed)
- Patients who have previously received an organ transplant other than a kidney
- Patients diagnosed with congestive heart failure within 6 months (EF <35%)
- Patients with untreated ischemic heart disease
- Patients whose hemoglobin is in the level of <7.0 g/dL
- Patients who have a known hypersensitivity to tacrolimus
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 |
|---|---|---|
| TacrolimusAlso: TacroBellTacrolimus for maintenance immunosupression in kidney transplant recipients | Drug | Tacrolimus conversion group |
Primary outcome
Change from Baseline in Blood Pressure at 6 months
Time frame: 3 months, 6 months
Change from Baseline in Lipid Profile at 6 months
Time frame: 3 months, 6 months
4 secondary outcomes
Assessing glucose regulation using blood glucose and hemoglobin A1c
Time frame: 3 months, 6 months
Assessing other metabolic cardiovascular risk factors using fibrinogen, tPA, PAI-I, homocysteine, pro-BNP, hs-CRP, uric acid
Time frame: 24 weeks
Assessing serum metabolite using ELISA
Time frame: 3 months, 6 months
Assessing renal function using blood urea nitrogen and creatinine
Time frame: 3 months, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2015.
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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.
Chan-Duck Kim, M.D., PhD contact
Chan-Duck Kim principal investigator
Kyungpook National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tacrolimus in people with CYCLOSPORINE/TACROLIMUS, run by Kyungpook National University Hospital at 1 site in South Korea.
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 9 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 14 Jul 2015. 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 South Korea. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Chan-Duck Kim, M.D., PhD (drcdkim@knu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Blood Pressure at 6 months (time frame: 3 months, 6 months). The study lists 2 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 14 Jul 2015.