Clinical trial NCT00302523: Tacrolimus Treatment of Patients With Idiopathic Membranous Nephropathy
Official title: Tacrolimus Treatment of Patients With Idiopathic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Membranous Nephropathy
Keywords: Idiopathic Membranous Nephropathy
Treatment
Tacrolimus
Cyclophosphamide
Lead sponsor: Nanjing University School of Medicine
Sponsor class: OTHER
First posted: 2006-03-14
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is:

* To explore the potential role of tacrolimus in the treatment of membranous nephropathy.
* To investigate the safety and tolerability of tacrolimus vs methylprednisolone plus cyclophosphamide.

Detailed description: Idiopathic membranous nephropathy is the most common cause of nephrotic syndrome in adults. Over the past decade, a number of studies have reported therapeutic efficacy for treatment with Cyclosporine-A (CSA) in patients with nephrotic syndrome including patients with membranous nephropathy. This study will evaluate the safety and effectiveness of a new calcineurin immunosuppressive drug, tacrolimus (FK506), in reducing the amount of protein in the urine in patients with membranous nephropathy. Forty patients with biopsy-proven membranous nephropathy will be recruited. Candidates must have completed at least six month of treatment with a stable dose of angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs). They will be screened with a medical history, physical examination, blood tests, and an examination for infection, cancers, and other conditions that can cause membranous nephropathy. The investigators plan to conduct an open-label study of the efficacy and safety of tacrolimus in the treatment of membranous nephropathy. They will be treated with oral tacrolimus for 6 months, followed by 6 months of maintenance. Proteinuria, renal function will be monitored. Complete remission is defined as 24-hour urinary protein excretion to less than 0.4 mg/day. This study will explore the potential role of tacrolimus in the treatment of membranous nephropathy, which is usually resistant to conventional therapy.

Eligibility criteria: Inclusion Criteria:

* Biopsy-proven idiopathic membranous nephropathy
* Nephrotic syndrome with proteinuria ( \> 4 g/day) and serum albumin \< 30 g/dl
* Age 18-60 years with informed consent

Exclusion Criteria:

* Patient with abnormal liver function tests
* Prior therapy with sirolimus, CSA, MMF, or azathioprin, cytoxan, chlorambucil, levamisole, methotrexate, or nitrogen mustard in the last 90 days
* Active/serious infection
* Patient with hepatitis B surface antigen or who is hepatitis C antibody positive
* Patient who is diabetic
* Patient is allergic or intolerant to macrolide antibiotics or tacrolimus

Primary outcomes:
measure: To explore the potential role of tacrolimus in the treatment of membranous nephropathy.
timeFrame: 18 months
Secondary outcomes:
measure: To investigate the safety and tolerability of tacrolimus vs intravenous CTX pulse.
timeFrame: 18 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
state: Jiangsu
city: Nanjing
country: China
facility: Research Institute of Nephrology, Jinling Hospital
state: Jiangsu
Study officials:
affiliation: Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
name: Zhi-hong Liu, M.D.
role: STUDY_DIRECTOR
References:
citation: von Groote TC, Williams G, Au EH, Chen Y, Mathew AT, Hodson EM, Tunnicliffe DJ. Immunosuppressive treatment for primary membranous nephropathy in adults with nephrotic syndrome. Cochrane Database Syst Rev. 2021 Nov 15;11(11):CD004293. doi: 10.1002/14651858.CD004293.pub4.