Kidney Transplant RecipientsPhase 4NCT02268201
A Study to Evaluate the Efficacy and Safety in Kidney Transplant Recipients When Changed From Cyclosporine to Tacrolimus Prolonged-release Capsule or Tacrolimus Capsule
A Phase 4 study testing Advagraf and Prograf in people with Kidney Transplant Recipients, run by Astellas Pharma China, Inc. at 7 sites in China.
Trial summary
KTx recipients receiving cyclosporine-based immunosuppressive therapy, and in the opinion of the investigator would benefit from switch to a tacrolimus-based immunosuppression, will switch the immunosuppressive therapy to a tacrolimus-based one. Efficacy and safety of patients will be observed for 52 weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Kidney Transplant Recipients
- What is being tested?
- Advagraf and Prograf
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 7 sitesChina
- Study dates
- 23 Jul 2013to 31 Mar 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients have received cyclosporine-based immunosuppressive therapy for more than 6 months， and have maintained a stable regimen for at least 8 weeks before enrollment
- The trough blood level of cyclosporine maintained at 50-200ng/ml at least 4 weeks before enrollment
- SCr< 200 μmol/l ( 2.3 mg/dl)
- Females of childbearing potential must have a negative pregnancy test within 48 hrs prior to randomization and reliable methods of contraception should be started 4 weeks prior to and during the whole study
- Understand and sign the approved informed consent form
Who cannot join
- Patients who have had other solid organ transplantations
- 24 hours proteinuria>2g
- SGPT/ALT，SGOT/AST or total bilirubin rising to more than double the normal level
- Patients suffering from serious infection lesions
- Patients have severe diarrhea or vomiting, peptic ulcer and/or defective absorption
- Patients have severe heart, lung disease, abnormal glucose tolerance or malignant tumor history
Show all 15Show fewer
- Known contraindication to administration of Tacrolimus. Subject has known hypersensitivity to tacrolimus, or any of the product excipients
- Pregnancy or lactating women
- Patients have participated in another clinical trial in the past month
- Patient refuses to sign informed consent form
- Patient not willing to continue in the study and wants to withdraw from the study
- Poor adherence or lost to follow-up
- Violation of protocol
- Severe adverse events occurred need to withdraw the study according to investigator's judgment
- Pregnancy
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Study site
Beijing
Study site
Fuzhou
Study site
Guangzhou
Study site
Jinan
Study site
Nanchang
Study site
Shanghai
Study site
Xi'an
About this study
Official title: A Randomized, Open-label, Multi-center Clinical Trial to Compare Efficacy and Safety of Cyclosporine-based and Switching Cyclosporine to Tacrolimus of Two Forms-based Immunosuppressive Therapy in Renal Transplant (KTx) Recipients
KTx recipients receiving cyclosporine-based immunosuppressive therapy, and in the opinion of the investigator would benefit from switch to a tacrolimus-based immunosuppression, will switch the immunosuppressive therapy to a tacrolimus-based one. Efficacy and safety of patients will be observed for 52 weeks.
Read the detailed description
The primary objective of this study is to compare the adherence of kidney transplant recipients treated with Prograf and Advagraf regimens.
The secondary objectives of this study are:
- To compare the renal function (eGFR) in KTx recipients treated with Cyclosporine and Tacrolimus regimens.
- To compare the QoL of KTx recipients treated with Cyclosporine and Tacrolimus regimens.
- To compare the efficacy of Cyclosporine and Tacrolimus regimens in KTx recipients.
- To compare the safety of Cyclosporine and Tacrolimus regimens in KTx recipients.
- Conditions
- Kidney Transplant Recipients
- Being tested
- Advagraf, Prograf
- Keywords
- tacrolimus, immunosuppressive therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdvagrafDrug
Also called Tacrolimus prolonged-release capsule
oral
PrografDrug
Also called Tacrolimus capsule
oral
| Study group | Role | What they receive |
|---|---|---|
| ADV group | Experimental | Once daily Receives: Drug: Advagraf |
| PRG group | Experimental | Twice daily Receives: Drug: Prograf |
What is being measured
The primary outcome is the main question the study is designed to answer.
medication adherence
VAS will be used to evaluate adherence between PRG and ADV
Measured: Up to 52 weeks after switching
Secondary outcomes (6)
endogenous creatinine clearance rate (Ccr)
Measured: Day 0, Week-1, Week2, Week-4, Week-8, Week-16, Week-24, Week36 and Week-52
Calculated glomerular filtration rate
Measured: Day 0, Week-1, Week2, Week-4, Week-8, Week-16, Week-24, Week36 and Week-52
blood lipids
total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol and triglyceride
Measured: Day 0, Week-1, Week2, Week-4, Week-8, Week-16, Week-24, Week36 and Week-52
liver function (AST, ALT and bilirubin)
Measured: Day 0, Week-1, Week2, Week-4, Week-8, Week-16, Week-24, Week36 and Week-52
fasting blood-glucose (FBG)
Measured: Day 0, Week-1, Week2, Week-4, Week-8, Week-16, Week-24, Week36 and Week-52
Safety assessed by the incidence and severity of adverse events
Measured: Up to 52 weeks after switching
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2014 (estimated)
- Study start23 Jul 2013
- Primary completion31 Mar 2015
- Study completion31 Mar 2015
Why it stopped: Due to difficulty enrolling patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 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
- NCT02268201
- Sponsor's protocol ID
- ACNKTxCon
- Status last verified
- Oct 2024
- First submitted
- 15 Oct 2014
- Last updated
- 1 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 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multi-center Clinical Trial to Compare Efficacy and Safety of Cyclosporine-based and Switching Cyclosporine to Tacrolimus of Two Forms-based Immunosuppressive Therapy in Renal Transplant (KTx) Recipients
- ClinicalTrials.gov ID
- NCT02268201
- Acronym / sponsor ID
- ACNKTxCon
- Conditions
- Kidney Transplant Recipients
- Keywords
- tacrolimus, immunosuppressive therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to difficulty enrolling patients
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Astellas Pharma China, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Jul 2013 (actual)
- Primary completion
- 31 Mar 2015 (actual)
- Study completion
- 31 Mar 2015 (actual)
- First posted
- 20 Oct 2014 (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.
KTx recipients receiving cyclosporine-based immunosuppressive therapy, and in the opinion of the investigator would benefit from switch to a tacrolimus-based immunosuppression, will switch the immunosuppressive therapy to a tacrolimus-based one. Efficacy and safety of patients will be observed for 52 weeks.
Detailed description
The primary objective of this study is to compare the adherence of kidney transplant recipients treated with Prograf and Advagraf regimens.
The secondary objectives of this study are:
- To compare the renal function (eGFR) in KTx recipients treated with Cyclosporine and Tacrolimus regimens.
- To compare the QoL of KTx recipients treated with Cyclosporine and Tacrolimus regimens.
- To compare the efficacy of Cyclosporine and Tacrolimus regimens in KTx recipients.
- To compare the safety of Cyclosporine and Tacrolimus regimens in KTx recipients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADV group | Experimental | Drug: AdvagrafOnce daily |
| PRG group | Experimental | Drug: PrografTwice daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients have received cyclosporine-based immunosuppressive therapy for more than 6 months， and have maintained a stable regimen for at least 8 weeks before enrollment
- The trough blood level of cyclosporine maintained at 50-200ng/ml at least 4 weeks before enrollment
- SCr< 200 μmol/l ( 2.3 mg/dl)
- Females of childbearing potential must have a negative pregnancy test within 48 hrs prior to randomization and reliable methods of contraception should be started 4 weeks prior to and during the whole study
- Understand and sign the approved informed consent form
Key exclusion criteria (15 listed)
- Patients who have had other solid organ transplantations
- 24 hours proteinuria>2g
- SGPT/ALT，SGOT/AST or total bilirubin rising to more than double the normal level
- Patients suffering from serious infection lesions
- Patients have severe diarrhea or vomiting, peptic ulcer and/or defective absorption
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 |
|---|---|---|
| AdvagrafAlso: Tacrolimus prolonged-release capsuleoral | Drug | ADV group |
| PrografAlso: Tacrolimus capsuleoral | Drug | PRG group |
Primary outcome
medication adherence
Time frame: Up to 52 weeks after switching
VAS will be used to evaluate adherence between PRG and ADV
6 secondary outcomes
endogenous creatinine clearance rate (Ccr)
Time frame: Day 0, Week-1, Week2, Week-4, Week-8, Week-16, Week-24, Week36 and Week-52
Calculated glomerular filtration rate
Time frame: Day 0, Week-1, Week2, Week-4, Week-8, Week-16, Week-24, Week36 and Week-52
blood lipids
Time frame: Day 0, Week-1, Week2, Week-4, Week-8, Week-16, Week-24, Week36 and Week-52
liver function (AST, ALT and bilirubin)
Time frame: Day 0, Week-1, Week2, Week-4, Week-8, Week-16, Week-24, Week36 and Week-52
fasting blood-glucose (FBG)
Time frame: Day 0, Week-1, Week2, Week-4, Week-8, Week-16, Week-24, Week36 and Week-52
Safety assessed by the incidence and severity of adverse events
Time frame: Up to 52 weeks after switching
Results and safety
The study was stopped early (reason given: Due to difficulty enrolling patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 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/.
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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 Inc
7 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 Advagraf and Prograf in people with Kidney Transplant Recipients, run by Astellas Pharma China, Inc. at 7 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 5 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 1 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 7 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 was stopped early (reason given: Due to difficulty enrolling patients). 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?
medication adherence (time frame: Up to 52 weeks after switching). 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 1 Nov 2024.