Tacrolimus Treatment of Patients With Idiopathic Membranous Nephropathy

Idiopathic Membranous Nephropathy Clinical Trial

Official title:

Tacrolimus Treatment of Patients With Idiopathic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00302523
• Other study ID #: NJCT-0603
• Status: Completed
• Phase: N/A
• First received: March 13, 2006
• Last updated: February 2, 2012
• Start date: March 2006
• Est. completion date: December 2009

Study information

• Verified date: February 2012
• Source: Nanjing University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glomerulonephritis, Membranous
• Idiopathic Membranous Nephropathy
• Kidney Diseases

Intervention

Drug:
• Tacrolimus
FK506,0.1mg/kg/d

Locations

Country	Name	City	State
China	Research Institute of Nephrology, Jinling Hospital	Nanjing	Jiangsu
China	Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To explore the potential role of tacrolimus in the treatment of membranous nephropathy.		18 months	Yes
Secondary	To investigate the safety and tolerability of tacrolimus vs intravenous CTX pulse.		18 months	Yes