The Focal and Segmental Glomerulosclerosis (FSGS) Clinical Trial, a
NIH/NIDDK-sponsored multi-center prospective randomized trial of
treatment of steroid resistant focal and segmental
glomerulosclerosis, seeks your assistance to identify patients as
prospective enrollees in the study. As we as a group are
collectively responsible for evaluating a large portion of the kidney
biopsies performed in the United States and Canada, we are in a
unique position to help in this project.
This study is interested in enrolling patients age 2 to 40 years who
have primary FSGS with a minimum urine protein/creatinine ratio of
1.0 g/g and a GFR of 40 ml/min/1.73m2 or greater.
We envision that when a biopsy specimen is read as FSGS and results
are discussed with the responsible nephrologist, you inform him/her
of the existence of the study. A study coordinator from one of the
five FSGS core coordinating centers would contact your office monthly
to obtain information on all biopsy specimens diagnosed as FSGS, the
date of the biopsy and the name and location of the nephrologist
responsible for that patient. It is not necessary to provide the
patient name; however, the pathology number should be provided (not a
HIPAA violation) to the coordinator who can use that information to
help the nephrologists identify potential patients to be entered into
the trial. At no time would the study coordinator directly contact
potential patients.
We believe that this is the best way to identify prospective
enrollees; your cooperation and help would be greatly appreciated.
Should you have any questions, do not hesitate to contact
Aaron Friedman, chair of the
steering committee for the FSGS-CT
Tel: 401 444-5648
Email: afriedman@lifespan.org
Thank you in advance for your assistance.
Vivette D'Agati
Charles E. Alpers
Arthur H. Cohen
James M. Pullman
Daniel Savino
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