Renal Transplant RecipientsPhase 4NCT02706678
Efficacy and Safety Study of the Switch From Cyclosporin to Tacrolimus in Renal Transplant Recipients
A Phase 4 study testing Tacrolimus sustained-release capsule in people with Renal Transplant Recipients, run by Astellas Pharma China, Inc. at 9 sites in China.
Trial summary
The objective of this study is to evaluate the effects of tacrolimus sustained-release capsules replacing cyclosporin on kidney function of renal transplant recipients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Renal Transplant Recipients
- What is being tested?
- Tacrolimus sustained-release capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 9 sitesChina
- Study dates
- 29 Dec 2010to 1 Aug 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years of age, male or female
- 1-5 years after kidney transplantation
- The patient has been accepting cyclosporin-based immunosuppressive therapy for ≥6 months, and the therapeutic regimen has kept stable for at least 4 weeks before inclusion
- The dose of cyclosporin has kept stable for at least 4 weeks before inclusion
- At least one of the cyclosporin-related adverse reactions is present or the answer to the 5th question in the questionnaire is "Yes" at the time of inclusion:
- gingival hyperplasia and treatment requested by the patient
Show all 11Show fewer
- polytrichia and interventional therapy requested by the patient
- post-transplantation hypertension
- post-transplantation hyperlipemia (total cholesterol>5.7 mmol/L (220 mg/dl))
- Serum creatinine<200 μmol/l ( 2.3 mg/dl)
- A promise is made to take contraceptive measures during the study (women at childbearing ages).
Who cannot join
- Patients having accepted transplantation of other organs apart from kidney transplantation
- Patients with 24-hour urine protein>2 g
- Patients with SGPT/ALT, SGOT/AST or total bilirubin continually increasing to more than twice the normal value(s)
- Patients with refractory infectious foci
- Patients with serious diarrhea or vomiting, active upper gastrointestinal ulcers or malabsorption
- Patients with serious heart or lung diseases or history of sugar tolerance abnormality or malignant tumors
Show all 10Show fewer
- Patients allergic to tacrolimus or other basic medications
- Pregnant or lactating women
- Patients having participated in other clinical trials within the previous month
- Other patients who are considered by doctors unsuitable for the study
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
Study site
Beijing
Study site
Changchun
Study site
Chengdu
Study site
Guangzhou
Study site
Nanjing
Study site
Nanning
Study site
Shanghai
Study site
Shenyang
Study site
Wuhan
About this study
Official title: Efficacy and Safety of a Post-transplantation Switch From Cyclosporin to Tacrolimus Sustained-release Capsules in Renal Transplant Recipients: A Multi-center, Open-label, Uncontrolled Study
The objective of this study is to evaluate the effects of tacrolimus sustained-release capsules replacing cyclosporin on kidney function of renal transplant recipients.
- Conditions
- Renal Transplant Recipients
- Being tested
- Tacrolimus sustained-release capsule
- Keywords
- FK506, Renal transplant recipients, cyclosporin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tacrolimus sustained-release capsuleDrug
Also called FK506
Oral
| Study group | Role | What they receive |
|---|---|---|
| Tacrolimus sustained-release capsule group | Experimental | Oral Receives: Drug: Tacrolimus sustained-release capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in creatinine level
Measured: Baseline and Week 24
Secondary outcomes (10)
Change from baseline in creatinine level
Measured: Baseline and Weeks 1, 2, 4, 8 and 12
Incidence of rejection reaction after drug use
Measured: Up to Week 24
Plasma concentrations of tacrolimus
Measured: Weeks 1, 2, 4, 8, 12 and 24
Change from baseline in blood pressure
Diastolic pressure and systolic pressure
Measured: Baseline and Weeks 1, 2, 4, 8, 12 and 24
Change from baseline in blood lipid
Total cholesterol, high density lipoprotein, low density lipoprotein, triglyceride
Measured: Baseline and Weeks 1, 2, 4, 8, 12 and 24
Change from baseline in liver function
Aspartate aminotransferase, alanine aminotransferase, bilirubin
Measured: Baseline and Weeks 1, 2, 4, 8, 12 and 24
Change from baseline in fasting blood glucose
Measured: Baseline and Weeks 1, 2, 4, 8, 12 and 24
Change from baseline in gingival hyperplasia
Measured: Baseline and Week 24
Change from baseline in polytrichia
Measured: Baseline and Week 24
Safety assessed by Adverse Events
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2016 (estimated)
- Study start29 Dec 2010
- Primary completion1 Aug 2012
- Study completion1 Aug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Transplant RecipientsStudies 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
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma China, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02706678
- Sponsor's protocol ID
- BJ309CT-02
- Status last verified
- Nov 2024
- First submitted
- 8 Mar 2016
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of a Post-transplantation Switch From Cyclosporin to Tacrolimus Sustained-release Capsules in Renal Transplant Recipients: A Multi-center, Open-label, Uncontrolled Study
- ClinicalTrials.gov ID
- NCT02706678
- Acronym / sponsor ID
- BJ309CT-02
- Conditions
- Renal Transplant Recipients
- Keywords
- FK506, Renal transplant recipients, cyclosporin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Astellas Pharma China, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Dec 2010 (actual)
- Primary completion
- 1 Aug 2012 (actual)
- Study completion
- 1 Aug 2012 (actual)
- First posted
- 11 Mar 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 evaluate the effects of tacrolimus sustained-release capsules replacing cyclosporin on kidney function of renal transplant recipients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tacrolimus sustained-release capsule group | Experimental | Drug: Tacrolimus sustained-release capsuleOral |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 18-65 years of age, male or female
- 1-5 years after kidney transplantation
- The patient has been accepting cyclosporin-based immunosuppressive therapy for ≥6 months, and the therapeutic regimen has kept stable for at least 4 weeks before inclusion
- The dose of cyclosporin has kept stable for at least 4 weeks before inclusion
- At least one of the cyclosporin-related adverse reactions is present or the answer to the 5th question in the questionnaire is "Yes" at the time of inclusion:
Key exclusion criteria (10 listed)
- Patients having accepted transplantation of other organs apart from kidney transplantation
- Patients with 24-hour urine protein>2 g
- Patients with SGPT/ALT, SGOT/AST or total bilirubin continually increasing to more than twice the normal value(s)
- Patients with refractory infectious foci
- Patients with serious diarrhea or vomiting, active upper gastrointestinal ulcers or malabsorption
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 |
|---|---|---|
| Tacrolimus sustained-release capsuleAlso: FK506Oral | Drug | Tacrolimus sustained-release capsule group |
Primary outcome
Change from baseline in creatinine level
Time frame: Baseline and Week 24
10 secondary outcomes
Change from baseline in creatinine level
Time frame: Baseline and Weeks 1, 2, 4, 8 and 12
Incidence of rejection reaction after drug use
Time frame: Up to Week 24
Plasma concentrations of tacrolimus
Time frame: Weeks 1, 2, 4, 8, 12 and 24
Change from baseline in blood pressure
Time frame: Baseline and Weeks 1, 2, 4, 8, 12 and 24
Change from baseline in blood lipid
Time frame: Baseline and Weeks 1, 2, 4, 8, 12 and 24
Change from baseline in liver function
Time frame: Baseline and Weeks 1, 2, 4, 8, 12 and 24
Change from baseline in fasting blood glucose
Time frame: Baseline and Weeks 1, 2, 4, 8, 12 and 24
Change from baseline in gingival hyperplasia
Time frame: Baseline and Week 24
Change from baseline in polytrichia
Time frame: Baseline and Week 24
Safety assessed by Adverse Events
Time frame: Up to 24 weeks
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 8 Nov 2024.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Related trials for Renal Transplant Recipients
RecruitingPhase 2
A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
Antibody-Mediated Rejection (AMR)
Not yet recruitingEarly Phase 1
Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
Kidney Transplant Recipient
Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Pediatric Kidney Disease, Transplant;Failure,Kidney
Not yet recruitingPhase 2
(TNX-1500) in Kidney Transplant Recipients
Kidney Transplant, Kidney Transplant Failure and Rejection
Not yet recruitingPhase 2/3
Semaglutide for the Prevention Of Post-Transplant Diabetes Mellitus
Kidney Transplant Recipient
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 Inc
9 sites 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 sustained-release capsule in people with Renal Transplant Recipients, run by Astellas Pharma China, Inc. at 9 sites in China.
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 11 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 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. 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 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?
Change from baseline in creatinine level (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 8 Nov 2024.