Pilot Studies of Novel Therapies to Treat Resistant Focal Segmental Glomerulosclerosis (FSGS)

Conditions

• Focal Glomerulosclerosis

Eligibility Criteria

Sex

ALL

Age

2 Years - 40 Years

Healthy Volunteers

Not accepted

Interventions

• Rosiglitazone (Avandia) — DRUG
  oral drug administration
• Adalimumab (Humira) — DRUG
  Injection of drug biweekly

Study Details

The current management of primary FSGS is predicated on the assumption that the disease is caused by an immune-mediated disturbance in glomerular barrier function. Therefore, most treatment protocols have involved immunosuppressive drugs given singly or in combination. However, the efficacy of this type of therapy has been disappointing and the long-term prognosis for renal survival in patients with resistant FSGS is poor. An alternative approach that targets the fibrosis pathway may represent a novel approach to the treatment of resistant FSGS. In this R21, the investigators will test the hypothesis that two novel agents - a tumor necrosis factor-alpha (TNF-α) antagonist and a peroxisome proliferator activator receptor-gamma (PPARγ) agonist - can be administered safely to patients with resistant FSGS. In the R21 feasibility/pilot phase, pharmacokinetic studies will be conducted to assess the impact of proteinuria on the kinetics of the novel drugs in children and adults. Specific Aim #1: To assess the safety and tolerability of two novel drugs - a TNF-α antagonist and a PPARγ agonist - in patients with resistant FSGS. Specific Aim #2: To conduct a pharmacokinetic (PK) assessment of the selected agents to enable selection of medication regimens for investigation in a randomized Phase II study.

Key Dates

Start date

Jul 31, 2005

Status verified

Oct 2007

Completion

Oct 31, 2007

Study Design

Enrollment

21 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: 1
  Avandia (rosiglitazone)
• Active Comparator: 2
  Humira (adalimumab)

Primary Outcome Measure

Safety and tolerance of medications [ Time Frame: 16 week treatment period ]

Locations (2)

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