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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00302523
Other study ID # NJCT-0603
Secondary ID
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


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
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