The NephCure Archive of FSGS Trials and Workshop -
January 2005
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has invested a sum approaching $12 million for a nationwide Clinical Trial of drugs for patients with FSGS. But the number of patients recruited thus far is far below what researchers had hoped.
Officials of the FSGS Clinical trial urge FSGS patients to visit the trial web site (www.fsgstrial.org) to learn more details and then to discuss the trial with their nephrologist.
There are 150 participating medical centers throughout the U.S. participating in the trial, which are offering either one of two drugs (cyclosporine or mycophenolate mofetil) to FSGS patients aged 2 to 35 over an 18-month period. The patients, who also will be given other drugs which have shown some success, will be followed for several years after medications are given.
The trial is the first nationwide attempt to test the value of immunosuppressant drugs against FSGS, which is caused when the kidney’s filters (glomeruli) leak protein for such a prolonged period that the filters scar. Eventually the kidneys are destroyed, requiring the patient to go on dialysis or seek a transplanted organ.
While FSGS is relatively uncommon, incidence of the condition has been rising and Josephine Briggs, M.D., former director of the NIDDK division that deals with kidney diseases, has referred to “the enormous health burden of the disorder.”
The Clinical Trial web site at www.fsgstrial.org has information about the trial for both patients and physicians.
However, officials connected with the trial stressed that the best way for patients to learn if they may enter the Trial is to see the nephrologist who is handling their FSGS.
Those running the trial clearly have been unhappy with the slow start of patient enrollment and have fretted that either the word has not gotten out to nephrologists or nephrologists may not understand precisely how the Trial works.
“If I could talk to every nephrologist, I would say: ‘Look, this is a study for you and your patients’,” said Debbie Gipson, M.D., principal investigator at the University of North Carolina at Chapel Hill, N.C., one of five major centers coordinating the study. “The study medications and study visits are managed in the outpatient (routine visit) setting. “
Dr. Gipson explained that the 150 participating centers include both private and university based nephrology practices. “We hope that many patients will find that their physician is already involved. “That way patients won’t have to feel that they are losing sight of their physician,” she said.
There are eligibility criteria that can exclude certain patients from the Trial protocol, such as previous use of drugs being tested. But Dr. Gipson noted that even those patients should ask their nephrologist about the Trial. The reason: These patients may qualify for alterative or “novel” therapy programs designed for those who either do not qualify for the Trial itself or who are not helped by the major Trial medications.
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