Tacrolimus Monotherapy for Idiopathic Membranous Nephropathy (IMN)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03549663
• Date of registration: 10/05/2018
• Prospective Registration: Yes
• Primary sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Public title: Tacrolimus Monotherapy for Idiopathic Membranous Nephropathy (IMN)
• Scientific title: Random, Open, Control and Monocentric Clinical Research on Tacrolimus Monotherapy for Idiopathic Membranous Nephropathy (IMN)
• Date of first enrolment: July 4, 2018
• Target sample size: 108
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03549663
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

China

Contacts

• Name: Fujun Lin, MD,PhD
• Affiliation: Shanghai Xinhua Hospital affiliated to Shanghai Jiao Tong University, School of Medicine

• Name: Fujun Lin, MD,PhD

• Name: Fujun Lin, MD,PhD

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Age: 18 - 80 years;

2. Those whose clinical manifestation and renal biopsy pathologic diagnosis are IMN
(Stages I-IV) with secondary membranous nephropathy excluded;

3. 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

- 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.

4. 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;

5. Patients who have signed the informed consent forms.

Exclusion Criteria:

1. Those whose kidney pathological manifestation of interstitial fibrosis is >30%;

2. 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;

3. Those who suffer from untreated active digestive tract ulcer within 3 months before
random grouping;

4. Those who suffer from uncured malignant tumor for less than 5 years

5. 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);

6. Those whose ALT, AST or total bilirubin content goes beyond 1.5 times above normal
upper limit;

7. Those who suffer from combined critical complications such as serious infection or
other severe organ disease or dysfunction;

8. Pregnant or lactating women;

9. Those who are known to be allergic to drugs under trial or relevant products;

10. Those who participated in other clinical trials within 3 months before inclusion;

11. The patients who cannot comply with the research proposal as determined by the
supervising physician.

Exit criteria

1. Those with incomplete or partial relieved proteinuria for 6 months after treatment;

2. Patients or their legal guardians voluntarily requests to withdraw;

3. Those against the inclusion criteria and exclusion criteria;

4. Those who need to take medications prohibited by the trail;

5. Those with poor compliance or stopping the drug for over 2 weeks;

6. Those with uncontrollable infection;

7. Those whit elevated blood glucose during the treatment, which is still difficult to
control after routine treatment by endocrinologists;

8. 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;

9. 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;

10. Those with other unexplained severe comorbidities;

11. Those with pregnancy during treatment;

12. For security reasons, the research sponsor proposed to stop the study;



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Membranous Nephropathy

Intervention(s)

Drug: Prednisone

Drug: Tacrolimus

Primary Outcome(s)

Complete remission rate of 24-hour urine protein [Time Frame: At week 48]

Secondary Outcome(s)

Number of patients with adverse events [Time Frame: up to 48 weeks]

PLA2R antibody negative conversion rate [Time Frame: At week 48]

Partial remission remission rate of 24-hour urine protein [Time Frame: At week 48]

Secondary ID(s)

XH-18-006

Source(s) of Monetary Support

Please refer to primary and secondary sponsors