Clinical trial NCT00302536: Tacrolimus Treatment of Patients With Idiopathic Focal Segmental Glomerulosclerosis
Official title: Tacrolimus Treatment of Patients With Idiopathic Focal Segmental
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Focal Glomerulosclerosis
Keywords: Idiopathic Focal Segmental Glomerulosclerosis
Treatment
Steroids
Lead sponsor: Nanjing University School of Medicine
Sponsor class: OTHER
First posted: 2006-03-14
Enrollment: 0
Sex: ALL
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy of Tacrolimus Treatment of patients with 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 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

Primary outcomes:
measure: To assess the efficacy of Tacrolimus Treatment Idiopathic Focal Segmental Glomerulosclerosis
timeFrame: 18 months
Secondary outcomes:
measure: To investigate the safety and tolerability of Tacrolimus vs Steroids in Treatment Idiopathic Focal Segmental Glomerulosclerosis
timeFrame: 18 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
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: Hodson EM, Sinha A, Cooper TE. Interventions for focal segmental glomerulosclerosis in adults. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD003233. doi: 10.1002/14651858.CD003233.pub3.