Kidney TransplantationPhase 4NCT02963103
A Study to Assess the Safety and Efficacy of a Tacrolimus Based Immunosuppressive Regimen in Stable Kidney Transplant Recipients Converted From Cyclosporine Based Immunosuppressive Regimen
A Phase 4 study testing Tacrolimus in people with Kidney Transplantation, run by Astellas Pharma Korea, Inc. at 1 site in South Korea.
Trial summary
The objective of this study is to observe and evaluate the change in renal function following conversion from cyclosporine-based immunosuppressive regimen to tacrolimus-based one. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Tacrolimus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2010to Oct 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients received a kidney transplant at least 12 months before enrollment.
- Patients whose dosage of previous immunosuppressants has not been changed and remained for at least 4 weeks before enrollment, and blood trough level of cyclosporine is 100 to 200 ng/mL.
- Patients who have the side effects (hypertension, hyperlipidemia, gingival hyperplasia and hypertrichosis/hirsutism) during use of cyclosporine.
- Serum creatinine < 2.3 mg/dl at enrollment
- Female patients of childbearing potential must have a negative serum pregnancy test prior to enrollment, and agreed to use effective contraception during the trial.
- Patients considered clinically stable
Who cannot join
- Patients who have previously received an organ transplant other than a kidney.
- Patients who have had acute transplant rejection within 12 weeks, or acute transplant rejection requiring antilymphocyte therapy within 24 weeks prior to enrollment.
- 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 have an underlying disease such as focal segmental glomerulosclerosis (FSGS) or type II membranoproliferative glomerulonephritis (Type II MPGN).
- Proteinuria > 2 g/24 hrs.
- Patients who have "Creeping creatinine" (a 20% increase in their creatinine for six months before their enrollment).
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- Patients whose Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) is twice higher than the normal range in the center.
- Patients who have liver cirrhosis.
- Patients who are pregnant or breastfeeding.
- Patients who had been HIV-positive.
- Patients who have a known allergy to Prograf® or its ingredients, steroids or adjuvants.
- Patients who have an unstable medical condition that may affect the evaluation of the study's objectives.
- Patients who are receiving prohibited concomitant medications or who received those medications within 28 days of their enrollment.
- Patients who are currently participating in another clinical trial or who received the investigational drug in another trial within 28 days of their enrollment.
- Patients who are at the risk of drug abuse or mental disorders or communicate difficulties.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center Pilot Study to Assess the Safety and Efficacy of a Tacrolimus Based Immunosuppressive Regimen in Stable Kidney Transplant Recipients Converted From Cyclosporine Based Immunosuppressive Regimen
The objective of this study is to observe and evaluate the change in renal function following conversion from cyclosporine-based immunosuppressive regimen to tacrolimus-based one.
- Conditions
- Kidney Transplantation
- Being tested
- Tacrolimus
- Keywords
- Tacrolimus, Kidney transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TacrolimusDrug
Also called Prograf (R)
Oral
| Study group | Role | What they receive |
|---|---|---|
| Tacrolimus group | Experimental | oral Receives: Drug: Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in GFR
GFR: glomerular filtration rate
Measured: Baseline and Week 24
Secondary outcomes (14)
Change from baseline in total cholesterol
Measured: Baseline and Week 24
Change from baseline in Triglycerides
Measured: Baseline and Week 24
Change from baseline in LDL
LDL: low density lipoprotein cholesterol
Measured: Baseline and Week 24
Change from baseline in HDL
HDL: high density lipoprotein cholesterol
Measured: Baseline and Week 24
Change from baseline in the number of antihyperlipidemic drugs
Measured: Baseline and Week 24
Change from baseline in blood pressure
Measured: Baseline and Week 24
Change from baseline in the number of antihypertensive drugs
Measured: Baseline and Week 24
Change from baseline in number of participants who have had hirsutism
Investigator's judgment
Measured: Baseline and Week 24
Change from baseline in number of participants who have had gingival hypertrophy
Investigator's judgment
Measured: Baseline and Week 24
Overall incidence rate of adverse events
Measured: up to Week 24
Proportion of participants with patient survival
Measured: up to Week 24
Proportion of participants with organ survival
Measured: up to Week 24
Acute rejection rate confirmed by biopsy
Measured: up to Week 24
Ratio of mean dose of cyclosporine to tacrolimus
Measured: up to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2016 (estimated)
- Study startMay 2010
- Primary completionOct 2012
- Study completionOct 2012
Why it stopped: Sponsor decision to terminate the study because subject enrollment was difficult.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Korea, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Korea, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02963103
- Sponsor's protocol ID
- PRG-KT-10-01
- Status last verified
- Nov 2016
- First submitted
- 6 Oct 2016
- Last updated
- 23 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center Pilot Study to Assess the Safety and Efficacy of a Tacrolimus Based Immunosuppressive Regimen in Stable Kidney Transplant Recipients Converted From Cyclosporine Based Immunosuppressive Regimen
- ClinicalTrials.gov ID
- NCT02963103
- Acronym / sponsor ID
- PRG-KT-10-01
- Conditions
- Kidney Transplantation
- Keywords
- Tacrolimus, Kidney transplantation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision to terminate the study because subject enrollment was difficult.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Astellas Pharma Korea, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 15 Nov 2016 (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 objective of this study is to observe and evaluate the change in renal function following conversion from cyclosporine-based immunosuppressive regimen to tacrolimus-based one.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tacrolimus group | Experimental | Drug: Tacrolimusoral |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients received a kidney transplant at least 12 months before enrollment.
- Patients whose dosage of previous immunosuppressants has not been changed and remained for at least 4 weeks before enrollment, and blood trough level of cyclosporine is 100 to 200 ng/mL.
- Patients who have the side effects (hypertension, hyperlipidemia, gingival hyperplasia and hypertrichosis/hirsutism) during use of cyclosporine.
- Serum creatinine < 2.3 mg/dl at enrollment
- Female patients of childbearing potential must have a negative serum pregnancy test prior to enrollment, and agreed to use effective contraception during the trial.
Key exclusion criteria (15 listed)
- Patients who have previously received an organ transplant other than a kidney.
- Patients who have had acute transplant rejection within 12 weeks, or acute transplant rejection requiring antilymphocyte therapy within 24 weeks prior to enrollment.
- 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 have an underlying disease such as focal segmental glomerulosclerosis (FSGS) or type II membranoproliferative glomerulonephritis (Type II MPGN).
- Proteinuria > 2 g/24 hrs.
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: Prograf (R)Oral | Drug | Tacrolimus group |
Primary outcome
Change from baseline in GFR
Time frame: Baseline and Week 24
GFR: glomerular filtration rate
14 secondary outcomes
Change from baseline in total cholesterol
Time frame: Baseline and Week 24
Change from baseline in Triglycerides
Time frame: Baseline and Week 24
Change from baseline in LDL
Time frame: Baseline and Week 24
Change from baseline in HDL
Time frame: Baseline and Week 24
Change from baseline in the number of antihyperlipidemic drugs
Time frame: Baseline and Week 24
Change from baseline in blood pressure
Time frame: Baseline and Week 24
Change from baseline in the number of antihypertensive drugs
Time frame: Baseline and Week 24
Change from baseline in number of participants who have had hirsutism
Time frame: Baseline and Week 24
Change from baseline in number of participants who have had gingival hypertrophy
Time frame: Baseline and Week 24
Overall incidence rate of adverse events
Time frame: up to Week 24
Proportion of participants with patient survival
Time frame: up to Week 24
Proportion of participants with organ survival
Time frame: up to Week 24
Acute rejection rate confirmed by biopsy
Time frame: up to Week 24
Ratio of mean dose of cyclosporine to tacrolimus
Time frame: up to Week 24
Results and safety
The study was stopped early (reason given: Sponsor decision to terminate the study because subject enrollment was difficult.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Kidney Transplantation
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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.
Medical Director study director
Astellas Pharma Korea, Inc.
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 Kidney Transplantation, run by Astellas Pharma Korea, Inc. 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 6 inclusion and 15 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: stopped early, as of the sponsor's last update on 23 Nov 2016. 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?
The study was stopped early (reason given: Sponsor decision to terminate the study because subject enrollment was difficult.). 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?
Change from baseline in GFR (time frame: Baseline and Week 24). 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 23 Nov 2016.