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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00193648
Date of registration: 10/09/2005
Prospective Registration: Yes
Primary sponsor: North Shore Long Island Jewish Health System
Public title: Pilot Studies of Novel Therapies to Treat Resistant Focal Segmental Glomerulosclerosis (FSGS)
Scientific title: Novel Therapies for Resistant FSGS
Date of first enrolment: July 2005
Target sample size: 21
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00193648
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 1
Countries of recruitment
United States
Contacts
Name:     Howard Trachtman, MD
Address: 
Telephone:
Email:
Affiliation:  Schneider Children's Hospital of North Shore-LIJ Health System
Name:     Tom Greene, PhD
Address: 
Telephone:
Email:
Affiliation:  The Cleveland Clinic
Name:     Debbie Gipson, MD
Address: 
Telephone:
Email:
Affiliation:  University of North Carolina
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Aged 2-42 years at onset of proteinuria

2. Aged = 42 years at time of randomization (randomization date before 43rd birthday)

3. Estimated glomerular filtration rate (GFR) = 40 ml/min/1.73 m2 at most recent
measurement prior to randomization

1. For patients < age 18 years: Schwartz formula

2. For patients = age 18 years: Cockroft-Gault formula

4. Up/c > 1.0 g/g creatinine on first morning void at time of randomization

5. Biopsy confirmed as primary FSGS (including all subtypes) by study pathologist.

6. Steroid resistance: During the last treatment course with high dose steroids prior
to randomization, the patient must have demonstrated steroid resistance defined below
and not have had a complete remission of proteinuria (Up/c < 0.2 or dipstick urine
protein negative/trace) subsequently. The course of steroid treatment that defines
resistance must be the same or equivalent to at least 4 weeks of every day dosing
with a minimum cumulative dose of 56 mg/kg or 1680 mg of prednisone or its
equivalent.

7. May be taking angiotensin-converting enzyme inhibitor (ACEI), angiotensin receptor
blocking agent (ARB), vitamin E, or lipid lowering therapy

8. Willingness to comply with clinical trial protocol, medications, and follow-up
visits, etc.

9. Screen failure in FSGS-CT based on prior treatment with excluded medication

10. Treatment failure in FSGS-CT based on failure to achieve remission after 26 weeks or
52 weeks of test therapy, i.e., cyclosporine or mycophenolate mofetil (MMF) + oral
dexamethasone pulses

Exclusion Criteria

1. Secondary FSGS

2. Treated with cyclophosphamide, chlorambucil, levamisole, methotrexate, nitrogen
mustard, or other immunosuppressive medications in the 30 days prior to
randomization

3. Lactation, pregnancy, or refusal of birth control in women of child bearing potential

4. Participation in another therapeutic trial concurrently or for 30 days prior to
randomization

5. Active/serious infection (including, but not limited to hepatitis B or C, HIV)

6. Malignancy

7. Systemic lupus erythematosus (SLE) or multiple sclerosis

8. Hepatic disease defined as serum AST/ALT > 2.5X the upper limit of normal

9. Patients with blood pressure > 140/95 or > 95th percentile for age/height while
receiving maximal doses of 3 or more antihypertensive agents.

10. Diabetes mellitus (DM) type I or II.

11. Hematocrit < 30%

12. Organ transplantation

13. Obesity (based on estimated dry weight at disease onset prior to steroid therapy)
defined as:

1. Body mass index (BMI) > 97th percentile for age if aged 2-20 years

2. BMI > 40 kg/m2 if aged = 21 years

14. Allergy to study medications

15. Inability to consent/assent



Age minimum: 2 Years
Age maximum: 40 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Focal Glomerulosclerosis
Intervention(s)
Drug: Adalimumab (Humira)
Drug: Rosiglitazone (Avandia)
Primary Outcome(s)
Safety and tolerance of medications [Time Frame: 16 week treatment period]
Secondary Outcome(s)
Reduction in proteinuria [Time Frame: 16 week treatment period]
Secondary ID(s)
DK70341
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
The Cleveland Clinic
University of North Carolina
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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