DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Tacrolimus Treatment of Patients With Idiopathic Focal Segmental Glomerulosclerosis

Information source: Nanjing University School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Focal Glomerulosclerosis

Intervention: Tacrolimus (Drug)

Phase: N/A

Status: Withdrawn

Sponsored by: Nanjing University School of Medicine

Official(s) and/or principal investigator(s):
Zhi-hong Liu, M.D., Study Director, Affiliation: Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine

Summary

The purpose of this study is to assess the efficacy of Tacrolimus Treatment of patients with idiopathic focal segmental glomerulosclerosis.

Clinical Details

Official title: Tacrolimus Treatment of Patients With Idiopathic Focal Segmental

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: To assess the efficacy of Tacrolimus Treatment Idiopathic Focal Segmental Glomerulosclerosis

Secondary outcome: To investigate the safety and tolerability of Tacrolimus vs Steroids in Treatment Idiopathic Focal Segmental Glomerulosclerosis

Detailed description: Primary FSGS is a leading cause of end stage renal disease in adults, with complete loss of kidney function in 50% of patients over 10 years. Steroids, which are currently used to treat the disease, are effective in part of patients. Over the past decade, a number of studies have reported therapeutic efficacy for treatment with Cyclosporine-A (CSA) in patients with FSGS. Recent studies suggest that immunosuppressive therapy targeted against the calcineurin pathway of T-helper cells, for example, tacrolimus, may be effective in the treatment of primary FSGS. The experience with Tacrolimus (FK506) in the treatment of patients with FSGS has been limited to uncontrolled trials in adult patients.

Eligibility

Minimum age: 15 Years. Maximum age: 50 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Age 14-50 years at onset of signs or symptoms of FSGS

- Biopsy proven FSGS

- Estimated glomerular filtration rate (GFR) ≥ 40 ml/min/1. 73 m2

- Urine protein > 3. 5 g/24h

- Biopsy confirmed primary FSGS (including all subtypes)

- Willingness to follow the clinical trial protocol, including medications, and

baseline and follow-up visits and procedures Exclusion Criteria:

- Secondary FSGS

- Prior therapy with sirolimus, CSA, MMF, or azathioprin, cytoxan, chlorambucil

levamisole, methotrexate, or nitrogen mustard in the last 90 days

- Active/serious infection

- Malignancy

- Previously diagnosed diabetes mellitus type 1 or 2

- Clinical evidence of cirrhosis or chronic active liver disease

- History of significant gastrointestinal disorder

- Allergy to study medications, and Inability to consent/assent

Locations and Contacts

Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Nanjing, Jiangsu 210002, China
Additional Information

Starting date: March 2006
Last updated: February 8, 2012

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017