Idiopathic Membranous NephropathyNCT03549663
Tacrolimus Monotherapy for Idiopathic Membranous Nephropathy (IMN)
A study testing Tacrolimus and Prednisone in people with Idiopathic Membranous Nephropathy, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The trial is a random, open, control and monocentric trial. Mainly 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
- Idiopathic Membranous Nephropathy
- 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
- 108 participants
- Where
- 1 siteChina
- Study dates
- 4 Jul 2018to Oct 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 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 for less than 5 years
- Those who received glucocorticoid (prednisone or prednisolone), mycophenolatemofetil, tacrolimus, cyclosporine A and other drugs for treatment within 3 months before screen with a course of treatment exceeding 4 weeks or those who received cyclophosphamide (accumulated dose>1.0g);
- 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, Shanghai Municipality, 200092
Fujun Lin, MD,PhD
About this study
Official title: Random, Open, Control and Monocentric Clinical Research on Tacrolimus Monotherapy for Idiopathic Membranous Nephropathy (IMN)
The trial is a random, open, control and monocentric trial. Mainly to assess the urine protein remission rate of tacrolimus (TAC) monotherapy for idiopathic membranous nephropathy (IMN). Assuming that the urine protein remission rate of 48-week TAC for monotherapy of IMN is not lower than that in treatment group of TAC combined with glucocorticoid, attempt on de-hormonal therapy in the future IMN therapy can be attempted on the basis of the trial results.
- Conditions
- Idiopathic Membranous Nephropathy
- 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
Tacrolimus capsules: 0.5mg/pill, 50 pills/box, AstellasPharma (China) Co., Ltd.; Tacrolimus capsules: 1mg/pill, 50 pills/box, Hangzhou ZhongmeiHuadong Pharmacy Co., Ltd. Start to administer on the randomized grouping day (D0) with an initial dose by weight: initial dose of 0.05-0.075mg/kg/d (bid) following a strict administration interval of 12 hours or fasting or 2 hours after meal. Adjust TAC dose according to 24-hour urine protein, plasma concentration and eGFR changes. It is recommended that plasma trough concentration should be remained at 5-8ng/ml and TAC dose during the whole therapy stage should not be lower than 0.5mg/d. Drugs should be stopped if the 6-month therapy is ineffective. After 6-month therapy, for those whose urine protein achieved complete remission (CR) or partial remission (PR), TAC dose should be reduced gradually with a total therapy duration of 48 weeks.
PrednisoneDrug
Also called Glucocorticoid
Glucocorticoid (prednisone): 5mg/pill, 100 pills/bottle: Shanghai Sine Pharmaceutical Factory Co., Ltd. The initial dose of prednisone should be 0.5mg/kg/d orally (maximum dose of 40mg/d) and administration should be continued for 8-12 weeks; then reduced by the monthly decreased amount of 0.1mg/kg/d till to 0.2mg/kg/d (5-10mg) to maintain. Prednisone should be stopped after administration for the entire 48 weeks.
| 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 posted8 Jun 2018
- Study start4 Jul 2018
- Primary completionOct 2020 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Membranous NephropathyStudies 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
- 108 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fujun Lin, MD,PhD, Principal investigator, Shanghai Xinhua Hospital affiliated to Shanghai Jiao Tong University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03549663
- Sponsor's protocol ID
- XH-18-006
- Status last verified
- Apr 2019
- First submitted
- 10 May 2018
- Last updated
- 3 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhu P, Zhou FD, Wang SX, Zhao MH, Wang HY. Increasing frequency of idiopathic membranous nephropathy in primary glomerular disease: a 10-year renal biopsy study from a single Chinese nephrology centre. Nephrology (Carlton). 2015 Aug;20(8):560-6. doi: 10.1111/nep.12542.
PubMed 26086701Xu X, Wang G, Chen N, Lu T, Nie S, Xu G, Zhang P, Luo Y, Wang Y, Wang X, Schwartz J, Geng J, Hou FF. Long-Term Exposure to Air Pollution and Increased Risk of Membranous Nephropathy in China. J Am Soc Nephrol. 2016 Dec;27(12):3739-3746. doi: 10.1681/ASN.2016010093. Epub 2016 Jun 30.
PubMed 27365535Hofstra JM, Fervenza FC, Wetzels JF. Treatment of idiopathic membranous nephropathy. Nat Rev Nephrol. 2013 Aug;9(8):443-58. doi: 10.1038/nrneph.2013.125. Epub 2013 Jul 2.
PubMed 23820815du Buf-Vereijken PW, Branten AJ, Wetzels JF. Idiopathic membranous nephropathy: outline and rationale of a treatment strategy. Am J Kidney Dis. 2005 Dec;46(6):1012-29. doi: 10.1053/j.ajkd.2005.08.020.
PubMed 16310567KDIGO Clinical Practice Guideline for Glomerulonephritis. Kidney Int 2012, 2: 139-274.
Ponticelli C, Zucchelli P, Passerini P, Cesana B, Locatelli F, Pasquali S, Sasdelli M, Redaelli B, Grassi C, Pozzi C, et al. A 10-year follow-up of a randomized study with methylprednisolone and chlorambucil in membranous nephropathy. Kidney Int. 1995 Nov;48(5):1600-4. doi: 10.1038/ki.1995.453.
PubMed 8544420Ponticelli C, Altieri P, Scolari F, Passerini P, Roccatello D, Cesana B, Melis P, Valzorio B, Sasdelli M, Pasquali S, Pozzi C, Piccoli G, Lupo A, Segagni S, Antonucci F, Dugo M, Minari M, Scalia A, Pedrini L, Pisano G, Grassi C, Farina M, Bellazzi R. A randomized study comparing methylprednisolone plus chlorambucil versus methylprednisolone plus cyclophosphamide in idiopathic membranous nephropathy. J Am Soc Nephrol. 1998 Mar;9(3):444-50. doi: 10.1681/ASN.V93444.
PubMed 9513907Ramachandran R, Hn HK, Kumar V, Nada R, Yadav AK, Goyal A, Kumar V, Rathi M, Jha V, Gupta KL, Sakhuja V, Kohli HS. Tacrolimus combined with corticosteroids versus Modified Ponticelli regimen in treatment of idiopathic membranous nephropathy: Randomized control trial. Nephrology (Carlton). 2016 Feb;21(2):139-46. doi: 10.1111/nep.12569.
PubMed 26205759Xu J, Zhang W, Xu Y, Shen P, Ren H, Wang W, Li X, Pan X, Chen N. Tacrolimus combined with corticosteroids in idiopathic membranous nephropathy: a randomized, prospective, controlled trial. Contrib Nephrol. 2013;181:152-62. doi: 10.1159/000348475. Epub 2013 May 8.
PubMed 23689577Chen M, Li H, Li XY, Lu FM, Ni ZH, Xu FF, Li XW, Chen JH, Wang HY; Chinese Nephropathy Membranous Study Group. Tacrolimus combined with corticosteroids in treatment of nephrotic idiopathic membranous nephropathy: a multicenter randomized controlled trial. Am J Med Sci. 2010 Mar;339(3):233-8. doi: 10.1097/MAJ.0b013e3181ca3a7d.
PubMed 20220333Zhu LB, Liu LL, Yao L, Wang LN. Efficacy and Safety of Tacrolimus Versus Cyclophosphamide for Primary Membranous Nephropathy: A Meta-Analysis. Drugs. 2017 Feb;77(2):187-199. doi: 10.1007/s40265-016-0683-z.
PubMed 28084563Praga M, Barrio V, Juarez GF, Luno J; Grupo Espanol de Estudio de la Nefropatia Membranosa. Tacrolimus monotherapy in membranous nephropathy: a randomized controlled trial. Kidney Int. 2007 May;71(9):924-30. doi: 10.1038/sj.ki.5002215. Epub 2007 Mar 21.
PubMed 17377504Liang Q, Li H, Xie X, Qu F, Li X, Chen J. The efficacy and safety of tacrolimus monotherapy in adult-onset nephrotic syndrome caused by idiopathic membranous nephropathy. Ren Fail. 2017 Nov;39(1):512-518. doi: 10.1080/0886022X.2017.1325371.
PubMed 28562168Hoxha E, Thiele I, Zahner G, Panzer U, Harendza S, Stahl RA. Phospholipase A2 receptor autoantibodies and clinical outcome in patients with primary membranous nephropathy. J Am Soc Nephrol. 2014 Jun;25(6):1357-66. doi: 10.1681/ASN.2013040430. Epub 2014 Mar 7.
PubMed 24610926
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Random, Open, Control and Monocentric Clinical Research on Tacrolimus Monotherapy for Idiopathic Membranous Nephropathy (IMN)
- ClinicalTrials.gov ID
- NCT03549663
- Acronym / sponsor ID
- XH-18-006
- Conditions
- Idiopathic Membranous Nephropathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 4 Jul 2018 (actual)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 8 Jun 2018 (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.
The trial is a random, open, control and monocentric trial. Mainly to assess the urine protein remission rate of tacrolimus (TAC) monotherapy for idiopathic membranous nephropathy (IMN). Assuming that the urine protein remission rate of 48-week TAC for monotherapy of IMN is not lower than that in treatment group of TAC combined with glucocorticoid, attempt on de-hormonal therapy in the future IMN therapy can be attempted on the basis of the trial results.
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 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 for less than 5 years
- Those who received glucocorticoid (prednisone or prednisolone), mycophenolatemofetil, tacrolimus, cyclosporine A and other drugs for treatment within 3 months before screen with a course of treatment exceeding 4 weeks or those who received cyclophosphamide (accumulated dose>1.0g);
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 |
|---|---|---|
| TacrolimusTacrolimus capsules: 0.5mg/pill, 50 pills/box, AstellasPharma (China) Co., Ltd.; Tacrolimus capsules: 1mg/pill, 50 pills/box, Hangzhou ZhongmeiHuadong Pharmacy Co., Ltd. Start to administer on the randomized grouping day (D0) with an initial dose by weight: initial dose of 0.05-0.075mg/kg/d (bid) following a strict administration interval of 12 hours or fasting or 2 hours after meal. Adjust TAC dose according to 24-hour urine protein, plasma concentration and eGFR changes. It is recommended that plasma trough concentration should be remained at 5-8ng/ml and TAC dose during the whole therapy stage should not be lower than 0.5mg/d. Drugs should be stopped if the 6-month therapy is ineffective. After 6-month therapy, for those whose urine protein achieved complete remission (CR) or partial remission (PR), TAC dose should be reduced gradually with a total therapy duration of 48 weeks. | Drug | Tacrolimus combined with hormone therapy, Tacrolimus monotherapy |
| PrednisoneAlso: GlucocorticoidGlucocorticoid (prednisone): 5mg/pill, 100 pills/bottle: Shanghai Sine Pharmaceutical Factory Co., Ltd. The initial dose of prednisone should be 0.5mg/kg/d orally (maximum dose of 40mg/d) and administration should be continued for 8-12 weeks; then reduced by the monthly decreased amount of 0.1mg/kg/d till to 0.2mg/kg/d (5-10mg) to maintain. Prednisone should be stopped after administration for the entire 48 weeks. | 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 3 Apr 2019.
- Background: PubMed 26086701Zhu P, Zhou FD, Wang SX, Zhao MH, Wang HY. Increasing frequency of idiopathic membranous nephropathy in primary glomerular disease: a 10-year renal biopsy study from a single Chinese nephrology centre. Nephrology (Carlton). 2015 Aug;20(8):560-6. doi: 10.1111/nep.12542.
- Background: PubMed 27365535Xu X, Wang G, Chen N, Lu T, Nie S, Xu G, Zhang P, Luo Y, Wang Y, Wang X, Schwartz J, Geng J, Hou FF. Long-Term Exposure to Air Pollution and Increased Risk of Membranous Nephropathy in China. J Am Soc Nephrol. 2016 Dec;27(12):3739-3746. doi: 10.1681/ASN.2016010093. Epub 2016 Jun 30.
- Background: PubMed 23820815Hofstra JM, Fervenza FC, Wetzels JF. Treatment of idiopathic membranous nephropathy. Nat Rev Nephrol. 2013 Aug;9(8):443-58. doi: 10.1038/nrneph.2013.125. Epub 2013 Jul 2.
- Background: PubMed 16310567du Buf-Vereijken PW, Branten AJ, Wetzels JF. Idiopathic membranous nephropathy: outline and rationale of a treatment strategy. Am J Kidney Dis. 2005 Dec;46(6):1012-29. doi: 10.1053/j.ajkd.2005.08.020.
- BackgroundKDIGO Clinical Practice Guideline for Glomerulonephritis. Kidney Int 2012, 2: 139-274.
- Background: PubMed 8544420Ponticelli C, Zucchelli P, Passerini P, Cesana B, Locatelli F, Pasquali S, Sasdelli M, Redaelli B, Grassi C, Pozzi C, et al. A 10-year follow-up of a randomized study with methylprednisolone and chlorambucil in membranous nephropathy. Kidney Int. 1995 Nov;48(5):1600-4. doi: 10.1038/ki.1995.453.
- Background: PubMed 9513907Ponticelli C, Altieri P, Scolari F, Passerini P, Roccatello D, Cesana B, Melis P, Valzorio B, Sasdelli M, Pasquali S, Pozzi C, Piccoli G, Lupo A, Segagni S, Antonucci F, Dugo M, Minari M, Scalia A, Pedrini L, Pisano G, Grassi C, Farina M, Bellazzi R. A randomized study comparing methylprednisolone plus chlorambucil versus methylprednisolone plus cyclophosphamide in idiopathic membranous nephropathy. J Am Soc Nephrol. 1998 Mar;9(3):444-50. doi: 10.1681/ASN.V93444.
- Background: PubMed 26205759Ramachandran R, Hn HK, Kumar V, Nada R, Yadav AK, Goyal A, Kumar V, Rathi M, Jha V, Gupta KL, Sakhuja V, Kohli HS. Tacrolimus combined with corticosteroids versus Modified Ponticelli regimen in treatment of idiopathic membranous nephropathy: Randomized control trial. Nephrology (Carlton). 2016 Feb;21(2):139-46. doi: 10.1111/nep.12569.
- Background: PubMed 23689577Xu J, Zhang W, Xu Y, Shen P, Ren H, Wang W, Li X, Pan X, Chen N. Tacrolimus combined with corticosteroids in idiopathic membranous nephropathy: a randomized, prospective, controlled trial. Contrib Nephrol. 2013;181:152-62. doi: 10.1159/000348475. Epub 2013 May 8.
- Background: PubMed 20220333Chen M, Li H, Li XY, Lu FM, Ni ZH, Xu FF, Li XW, Chen JH, Wang HY; Chinese Nephropathy Membranous Study Group. Tacrolimus combined with corticosteroids in treatment of nephrotic idiopathic membranous nephropathy: a multicenter randomized controlled trial. Am J Med Sci. 2010 Mar;339(3):233-8. doi: 10.1097/MAJ.0b013e3181ca3a7d.
- Background: PubMed 28084563Zhu LB, Liu LL, Yao L, Wang LN. Efficacy and Safety of Tacrolimus Versus Cyclophosphamide for Primary Membranous Nephropathy: A Meta-Analysis. Drugs. 2017 Feb;77(2):187-199. doi: 10.1007/s40265-016-0683-z.
- Background: PubMed 17377504Praga M, Barrio V, Juarez GF, Luno J; Grupo Espanol de Estudio de la Nefropatia Membranosa. Tacrolimus monotherapy in membranous nephropathy: a randomized controlled trial. Kidney Int. 2007 May;71(9):924-30. doi: 10.1038/sj.ki.5002215. Epub 2007 Mar 21.
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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.
Fujun Lin, MD,PhD principal investigator
Shanghai Xinhua Hospital affiliated to Shanghai Jiao Tong University, School of Medicine
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 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 3 Apr 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?
On the ClinicalTrials.gov record for NCT03549663, which also lists 14 linked publications.
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 3 Apr 2019.