Kidney Transplant RecipientsPhase 4NCT05293704
An Open Study on the Preventive Effect of Early Mizoribine Conversion on BKV Nephropathy in Renal Transplant Recipients
A Phase 4 study testing Mizoribine in people with Kidney Transplant Recipients and BK Virus, run by Lee's Pharmaceutical Limited at 1 site in China.
Trial summary
This study is divided into two parts: ① Part I was a retrospective observational study. Kidney transplant recipients infected with BK virus (BKV) in the First Affiliated Hospital of Sun Yat-sen University from 2015 to 2021 were retrospectively collected and divided into case group and control group whether to convert… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Recipients, BK Virus
- What is being tested?
- Mizoribine
- Type of treatment
- Pill or oral medicine
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 1 May 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Kidney transplant recipients;
- Postoperative maintenance therapy with glucocorticoid + tacrolimus +MPA;
- Urinary BKV-DNA load ≥10^7/L;
- No gender limitation for recipients > 18 years of age;
- Voluntarily sign written informed consent.
Who cannot join
- Multiple organ transplantation;
- Acute rejection occurred within 1 week before enrollment;
- Recipients with signs of active infection;
- Recipients with white blood cell count below 3,000 /cubic metre;
- Women who are pregnant, breast-feeding, or unwilling to use appropriate contraceptive methods during the study period;
- Patients with serious gastrointestinal diseases and active peptic ulcer disease;
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- Suffering from any mental illness;
- Patients with severe heart disease and abnormal cardiac function;
- Subjects with known allergy to the test drug;
- Other competent physicians judged that the recipients were not suitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou
huan Yang, 15626450204
About this study
This study is divided into two parts: ① Part I was a retrospective observational study. Kidney transplant recipients infected with BK virus (BKV) in the First Affiliated Hospital of Sun Yat-sen University from 2015 to 2021 were retrospectively collected and divided into case group and control group whether to convert MPA drug to mizoribine. ② The second part was a prospective, open and interventional clinical trial. Thirty patients with positive urinary BK virus after kidney transplantation using Mycophenolic acid (MPA) were enrolled in the First Affiliated Hospital of Sun Yat-sen University. All patients who met the inclusion criteria were treated with mizoribine to place MPA (Mycophenolate or mycophenolate sodium enteric coated tablets) for 12 months as directed. At the baseline of follow-up (before enrollment) and at each follow-up point, clinical indicators of patients were recorded, and renal biopsy was performed to evaluate the occurrence of BKV nephropathy in patients with persistent elevated BK viruria or persistent BK viremia after conversion and patients with BK viruria after 12 months, and to judge the progress after early activation of BKV and the safety of mizoribine.
Read the detailed description
This study is divided into two parts: ① Part I was a retrospective observational study. Kidney transplant recipients infected with BK virus (BKV) in the First Affiliated Hospital of Sun Yat-sen University from 2015 to 2021 were retrospectively collected and divided into case group and control group whether to convert MPA drug to mizoribine. The basic data of the two groups, the concentration of mizoribine, the clinical benefit after conversion and the outcome of BKV infection were analyzed, and the clinical improvement rate and preliminary safety of mizoribine conversion on BKV infection were determined. ② The second part was a prospective, open and interventional clinical trial. Thirty patients with positive urinary BK virus after kidney transplantation using Mycophenolic acid (MPA) were enrolled in the First Affiliated Hospital of Sun Yat-sen University. The patients and their families voluntarily participated in the experiment and signed the Informed Consent on the premise of fully understanding the treatment plan. The treatment was approved by the hospital ethics Committee. All patients who met the inclusion criteria were treated with MPA (Mycophenolate or mycophenolate sodium enteric coated tablets) replaced with mizoribine for 12 months. At the baseline of follow-up (before enrollment) and at each follow-up point, clinical indicators of patients were recorded, and renal biopsy was performed to evaluate the occurrence of BKV nephropathy in patients with persistent elevated BK viruria or persistent BK viremia after conversion and patients with BK viruria after 12 months, and to judge the progress after early activation of BKV and the safety of mizoribine.
- Conditions
- Kidney Transplant Recipients, BK Virus
- Being tested
- Mizoribine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MizoribineDrug
Orally administered at 3-4 mg/kg/d, once every 12 hours; When body weight ≤50 kg, each dose of 75 mg; Weight \& gt At 50 kg, the dosage was 100 mg each time.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants who had BKV-related nephropathy occurred
During the follow-up, patients with urinary BKV-DNA increase of more than 10 times for 3 consecutive months after dressing change, or viremia (serum BKV-DNA load ≥10^4/ mL) for 3 consecutive months after dressing change, as well as patients with urinary BKV positive 12 months after dressing change, were evaluated by renal biopsy pathology. The number of Participants who had BKV-related nephropathy occurred will be counted.（BKV stands for BK polyoma virus）
Measured: 12 month
Secondary outcomes (3)
Number of Participants in who Serum and urine BK viral load were cleared
During the observation period, the presence of serum BKV and the corresponding BKV-DNA load of the subjects were recorded to determine the incidence and outcome of BKV.
Measured: 12 month
Number of Participants with Acute rejection
Diagnosis of acute rejection: including clinical diagnosis and pathological diagnosis. If the serum creatinine increased by more than 20% within 72 hours, acute rejection was suspected, and ultrasound examination of the transplanted kidney was performed, and biopsy of the transplanted kidney was performed if necessary. Acute rejection (BPAR) confirmed by biopsy needs to be diagnosed by a pathologist according to the classification criteria (1997 edition and subsequently updated). If not confirmed by biopsy, acute rejection should be diagnosed based on the exclusion of other causes of elevated creatinine.
Measured: 12 month
Number of Participants with Renal graft loss
During the study, renal function was recorded, the survival of transplanted kidneys was counted and the survival rate of transplanted kidneys was calculated.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start1 May 2022 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 May 2024 (estimated)
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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lee's Pharmaceutical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05293704
- Sponsor's protocol ID
- BLDN-LEES-2022-3
- Status last verified
- Mar 2022
- First submitted
- 12 Mar 2022
- Last updated
- 24 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Study on the Preventive Effect of Early Mizoribine Conversion on BKV Nephropathy in Renal Transplant Recipients
- ClinicalTrials.gov ID
- NCT05293704
- Acronym / sponsor ID
- BLDN-LEES-2022-3
- Conditions
- Kidney Transplant Recipients, BK Virus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Lee's Pharmaceutical LimitedIndustry (pharma, biotech, devices)
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 24 Mar 2022 (actual)
- 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.
This study is divided into two parts: ① Part I was a retrospective observational study. Kidney transplant recipients infected with BK virus (BKV) in the First Affiliated Hospital of Sun Yat-sen University from 2015 to 2021 were retrospectively collected and divided into case group and control group whether to convert MPA drug to mizoribine. ② The second part was a prospective, open and interventional clinical trial. Thirty patients with positive urinary BK virus after kidney transplantation using Mycophenolic acid (MPA) were enrolled in the First Affiliated Hospital of Sun Yat-sen University. All patients who met the inclusion criteria were treated with mizoribine to place MPA (Mycophenolate or mycophenolate sodium enteric coated tablets) for 12 months as directed. At the baseline of follow-up (before enrollment) and at each follow-up point, clinical indicators of patients were recorded, and renal biopsy was performed to evaluate the occurrence of BKV nephropathy in patients with persistent elevated BK viruria or persistent BK viremia after conversion and patients with BK viruria after 12 months, and to judge the progress after early activation of BKV and the safety of mizoribine.
Detailed description
This study is divided into two parts: ① Part I was a retrospective observational study. Kidney transplant recipients infected with BK virus (BKV) in the First Affiliated Hospital of Sun Yat-sen University from 2015 to 2021 were retrospectively collected and divided into case group and control group whether to convert MPA drug to mizoribine. The basic data of the two groups, the concentration of mizoribine, the clinical benefit after conversion and the outcome of BKV infection were analyzed, and the clinical improvement rate and preliminary safety of mizoribine conversion on BKV infection were determined. ② The second part was a prospective, open and interventional clinical trial. Thirty patients with positive urinary BK virus after kidney transplantation using Mycophenolic acid (MPA) were enrolled in the First Affiliated Hospital of Sun Yat-sen University. The patients and their families voluntarily participated in the experiment and signed the Informed Consent on the premise of fully understanding the treatment plan. The treatment was approved by the hospital ethics Committee. All patients who met the inclusion criteria were treated with MPA (Mycophenolate or mycophenolate sodium enteric coated tablets) replaced with mizoribine for 12 months. At the baseline of follow-up (before enrollment) and at each follow-up point, clinical indicators of patients were recorded, and renal biopsy was performed to evaluate the occurrence of BKV nephropathy in patients with persistent elevated BK viruria or persistent BK viremia after conversion and patients with BK viruria after 12 months, and to judge the progress after early activation of BKV and the safety of mizoribine.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Kidney transplant recipients;
- Postoperative maintenance therapy with glucocorticoid + tacrolimus +MPA;
- Urinary BKV-DNA load ≥10^7/L;
- No gender limitation for recipients > 18 years of age;
- Voluntarily sign written informed consent.
Key exclusion criteria (10 listed)
- Multiple organ transplantation;
- Acute rejection occurred within 1 week before enrollment;
- Recipients with signs of active infection;
- Recipients with white blood cell count below 3,000 /cubic metre;
- Women who are pregnant, breast-feeding, or unwilling to use appropriate contraceptive methods during the study period;
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 |
|---|---|---|
| MizoribineOrally administered at 3-4 mg/kg/d, once every 12 hours; When body weight ≤50 kg, each dose of 75 mg; Weight \& gt At 50 kg, the dosage was 100 mg each time. | Drug | – |
Primary outcome
Number of Participants who had BKV-related nephropathy occurred
Time frame: 12 month
During the follow-up, patients with urinary BKV-DNA increase of more than 10 times for 3 consecutive months after dressing change, or viremia (serum BKV-DNA load ≥10^4/ mL) for 3 consecutive months after dressing change, as well as patients with urinary BKV positive 12 months after dressing change, were evaluated by renal biopsy pathology. The number of Participants who had BKV-related nephropathy occurred will be counted.（BKV stands for BK polyoma virus）
3 secondary outcomes
Number of Participants in who Serum and urine BK viral load were cleared
Time frame: 12 month
Number of Participants with Acute rejection
Time frame: 12 month
Number of Participants with Renal graft loss
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
- Individual participant dataSharing planned: Undecided
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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.
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 Mizoribine in people with Kidney Transplant Recipients and BK Virus, run by Lee's Pharmaceutical Limited at 1 site 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 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: status not confirmed, as of the sponsor's last update on 24 Mar 2022. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang huan (15626450204, huan.yang@leespharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants who had BKV-related nephropathy occurred (time frame: 12 month). 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 24 Mar 2022.