TacrolimusNCT03864250
Tacrolimus Monotherapy for Idiopathic Membranous Nephropathy
A study testing Tacrolimus and Prednisone in people with Tacrolimus and Idiopathic Membranous Nephropathy, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
This random, open, control and multicenter clinical trial mainly aims to assess the urine protein remission rate of tacrolimus (TAC) monotherapy for idiopathic membranous nephropathy (IMN). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tacrolimus, Idiopathic Membranous Nephropathy, Clinical Trial
- What is being tested?
- Tacrolimus and Prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteChina
- Study dates
- 26 Nov 2018to Nov 2021
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 - 80 years;
- Those whose clinical manifestation and renal biopsy pathologic diagnosis are IMN (Stages I-IV) with secondary membranous nephropathy excluded;
- Those who meet any of the following high-risk IMN standards:
- Urinary protein>8g/24h
- Serum albumin<25g/l
- Serum PLA2R levels are 5 times higher than normal
Show all 10Show fewer
- eGFR decline rate after confirmed IMN within 6-12 months is ≥30%
- Patients with serious complications: pulmonary embolism, lower extremity static Vein thrombosis/embolism, acute renal injury, etc.
- Those without reaching the above high-risk IMN standard, but their course of disease is >6 months without spontaneous remission,and still present nephrotic syndrome;
- Patients who have signed the informed consent forms.
Who cannot join
- Those whose kidney pathological manifestation of interstitial fibrosis is >30%;
- Those who are positive in active Hepatitis B (including HBsAg, HBeAg and HBcAb or HBsAg, HBeAb and HBC) or serological indexes (HBsAg or/and HBeAg or/and HBcAb) or infected with Hepatitis C, tuberculosis, cytomegalovirus, severe fungal infection, syphilis or HIV infection;
- Those who suffer from untreated active digestive tract ulcer within 3 months before random grouping;
- Those who suffer from uncured malignant tumor less than 5 years;
- Those who received glucocorticoids (prednisone or prednisolone), mycophenolate mofetil, tacrolimus, cyclosporine A, cyclophosphamide, tripterygium and other immunosuppressive agents for treatment within 3 months before screening;
- Those whose ALT, AST or total bilirubin content goes beyond 1.5 times above normal upper limit;
Show all 24Show fewer
- Those who suffer from combined critical complications such as serious infection or other severe organ disease or dysfunction;
- Pregnant or lactating women;
- Those who are known to be allergic to drugs under trial or relevant products;
- Those who participated in other clinical trials within 3 months before inclusion;
- The patients who cannot comply with the research proposal as determined by the supervising physician.
- Exit criteria
- Those with incomplete or partial relieved proteinuria for 6 months after treatment;
- Patients or their legal guardians voluntarily requests to withdraw;
- Those against the inclusion criteria and exclusion criteria;
- Those who need to take medications prohibited by the trail;
- Those with poor compliance or stopping the drug for over 2 weeks;
- Those with uncontrollable infection;
- Those whit elevated blood glucose during the treatment, which is still difficult to control after routine treatment by endocrinologists;
- In the TAC group, the eGFR decreased by >30%, the TAC dose was halved. And the drug concentration and renal function were reviewed after 2 weeks. If the eGFR decreased by <30%, it will continue to be used; if the eGFR still decreased by >30%, the TAC dose continues to halve, or give a minimum dose of 0.5mg / d. And the drug concentration and renal function were reviewed after 2 weeks. If the eGFR decreased by <30%, TAC will continue to be used, otherwise stop the drug;
- Those whose ALT, AST or bilirubin rises to more than 2 times the upper limit of normal value after treatment, and continues to increase for 2 weeks; those whose ALT, AST or bilirubin rises to more than 2 times the upper limit of normal value after 2 weeks of treatment with liver protection, the drug will be discontinued. If it cannot be recovered after 2 weeks, the patient will withdraw;
- Those with other unexplained severe comorbidities;
- Those with pregnancy during treatment;
- For security reasons, the research sponsor proposed to stop the study;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Xinhua Hospital affliated to Shanghai Jiao Tong University, School of Medicine
Shanghai
Fujun Lin
About this study
Official title: Tacrolimus Monotherapy for Idiopathic Membranous Nephropathy: A Randomized, Open, Controlled, Multicenter Clinical Trial
This random, open, control and multicenter clinical trial mainly aims to assess the urine protein remission rate of tacrolimus (TAC) monotherapy for idiopathic membranous nephropathy (IMN).
- Being tested
- Tacrolimus, Prednisone
- Medical subject headings
- Glomerulonephritis, Membranous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TacrolimusDrug
The initial dose of TAC is 0.05-0.1 mg/kg/d, taking 2 hours before and after meals. The interval is strictly 12 hours. The blood concentration is measured after taking the drug. According to the concentration of blood drug valley, the dose of tacrolimus (blood concentration of ≤10ng/ml) is adjusted. If the blood drug concentration is low, the drug dose (≤0.1mg/kg/d) is increased accordingly. After 6 months of treatment, the drug is discontinued. The TAC dose is maintained at the original dose after 6 months of treatment with complete or partial remission of urinary protein until the end of the 48-week trial.
PrednisoneDrug
The initial dose of prednisone is 0.5 mg/kg/d orally (maximum dose 40 mg/d), and after 8-12 weeks, the dose was gradually reduced until discontinuation. TAC treatment is given at the same time (the treatment plan is the same as the experimental group).
| Study group | Role | What they receive |
|---|---|---|
| Tacrolimus monotherapy | Experimental | Not described Receives: Drug: Tacrolimus |
| Tacrolimus combined with hormone therapy | Active comparator | Not described Receives: Drug: Tacrolimus; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete remission rate of 24-hour urine protein
The proportion of patients with complete remission of 24-hour urine protein in the total evaluated patients. Evaluation criteria of complete remission: post-therapy urine protein level is <0.3g/24h.
Measured: At week 48
Secondary outcomes (3)
Partial remission remission rate of 24-hour urine protein
The proportion of patients with partial remission of 24-hour urine protein in the total evaluated patients. Evaluation criteria of partial remission: post-therapy urine protein decline is >50% compared with the peak value.
Measured: At week 48
PLA2R antibody negative conversion rate
The proportion of patients with PLA2R antibody negative conversion in the total evaluated patients. Evaluation criteria of negative conversion: PLA2R antibody level is <20RU/ml.
Measured: At week 48
Number of patients with adverse events
Number of patients with adverse events
Measured: Up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start26 Nov 2018
- Primary completionNov 2020 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TacrolimusStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03864250
- Sponsor's protocol ID
- XH-19-002
- Status last verified
- Mar 2019
- First submitted
- 4 Mar 2019
- Last updated
- 25 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tacrolimus Monotherapy for Idiopathic Membranous Nephropathy: A Randomized, Open, Controlled, Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT03864250
- Acronym / sponsor ID
- XH-19-002
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 26 Nov 2018 (actual)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 6 Mar 2019 (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 random, open, control and multicenter clinical trial mainly aims to assess the urine protein remission rate of tacrolimus (TAC) monotherapy for idiopathic membranous nephropathy (IMN).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tacrolimus monotherapy | Experimental | Drug: Tacrolimus |
| Tacrolimus combined with hormone therapy | Active comparator | Drug: Tacrolimus, Drug: Prednisone |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age: 18 - 80 years;
- Those whose clinical manifestation and renal biopsy pathologic diagnosis are IMN (Stages I-IV) with secondary membranous nephropathy excluded;
- Those who meet any of the following high-risk IMN standards:
- Those without reaching the above high-risk IMN standard, but their course of disease is >6 months without spontaneous remission,and still present nephrotic syndrome;
- Patients who have signed the informed consent forms.
Key exclusion criteria (24 listed)
- Those whose kidney pathological manifestation of interstitial fibrosis is >30%;
- Those who are positive in active Hepatitis B (including HBsAg, HBeAg and HBcAb or HBsAg, HBeAb and HBC) or serological indexes (HBsAg or/and HBeAg or/and HBcAb) or infected with Hepatitis C, tuberculosis, cytomegalovirus, severe fungal infection, syphilis or HIV infection;
- Those who suffer from untreated active digestive tract ulcer within 3 months before random grouping;
- Those who suffer from uncured malignant tumor less than 5 years;
- Those who received glucocorticoids (prednisone or prednisolone), mycophenolate mofetil, tacrolimus, cyclosporine A, cyclophosphamide, tripterygium and other immunosuppressive agents for treatment within 3 months before screening;
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 |
|---|---|---|
| TacrolimusThe initial dose of TAC is 0.05-0.1 mg/kg/d, taking 2 hours before and after meals. The interval is strictly 12 hours. The blood concentration is measured after taking the drug. According to the concentration of blood drug valley, the dose of tacrolimus (blood concentration of ≤10ng/ml) is adjusted. If the blood drug concentration is low, the drug dose (≤0.1mg/kg/d) is increased accordingly. After 6 months of treatment, the drug is discontinued. The TAC dose is maintained at the original dose after 6 months of treatment with complete or partial remission of urinary protein until the end of the 48-week trial. | Drug | Tacrolimus combined with hormone therapy, Tacrolimus monotherapy |
| PrednisoneThe initial dose of prednisone is 0.5 mg/kg/d orally (maximum dose 40 mg/d), and after 8-12 weeks, the dose was gradually reduced until discontinuation. TAC treatment is given at the same time (the treatment plan is the same as the experimental group). | Drug | Tacrolimus combined with hormone therapy |
Primary outcome
Complete remission rate of 24-hour urine protein
Time frame: At week 48
The proportion of patients with complete remission of 24-hour urine protein in the total evaluated patients. Evaluation criteria of complete remission: post-therapy urine protein level is <0.3g/24h.
3 secondary outcomes
Partial remission remission rate of 24-hour urine protein
Time frame: At week 48
PLA2R antibody negative conversion rate
Time frame: At week 48
Number of patients with adverse events
Time frame: Up to 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2019.
Related trials for Tacrolimus
Active, not recruitingPhase 4
Tacrolimus C:D Ratio Measured in Renal Transplant Recipients Treated With Once-daily Prolonged-release Drugs
Immunosuppression
Not yet recruiting
Efficacy of Fractional Co2 Laser With Topical Tacrolimus 0.1 in the Treatment of Nail Psoriasis
Nail Psoriasis
RecruitingPhase 2
A Study Comparing Siplizumab With Rabbit Anti-Thymocyte Globulin to Help the Body Accept a Kidney Transplant
Renal Transplant Failure and Rejection
Enrolling by invitation
Topical Ruxolitinib Versus Tacrolimus With Excimer Laser for Localized Vitiligo
Vitiligo, Nonsegmental Vitiligo
RecruitingPhase 2
Trial of 2 Step ATG for Prevention of Acute GVHD Post Allogeneic Stem Cell Transplant
Acute Leukemia, Myelodysplastic Syndrome
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 study testing Tacrolimus and Prednisone in people with Tacrolimus and Idiopathic Membranous Nephropathy, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine 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 10 inclusion and 24 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 25 Jun 2019. 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.
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 Fujun Lin, MD,PhD (+86-13917983703, linfujun@xinhuamed.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete remission rate of 24-hour urine protein (time frame: At week 48). 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 25 Jun 2019.