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INFORMATION FOR INVESTIGATORS & COORDINATORS
FAQs For CoordinatorsWhy is pulse dexamethasone being used in the FSGS Clinical Trial?Dexamethasone pulse therapy was chosen for the trial based on a pilot study in patients with FSGS by Dr. Jeffrey Kopp at the NIH. The pulse dosing of dexamethasone has been selected to provide an opportunity to minimize the side effects, as the dose is given only two days of each dosing week. Dr. Kopp's early study has shown this approach to be a safe option. Does equipoise exist in the FSGS Study?Equipoise, or the true possibility for either treatment assignment to be the best, does exist for this study. The cyclosporine arm is considered to be a standard therapeutic approach for corticosteroid resistant FSGS. In published studies, cyclosporine can result in a 70% response rate during treatment. This 70% response leaves room for improvement. The alternate treatment arm of dexamethasone pulses coupled with Mycophenolate Mofetil was designed to have the potential for a better response rate, but this has not been proven. History is rife with examples where we believe that one therapy is better than another and then a well-designed clinical trial proves the opposite. The FSGS Clinical Trial will provide an answer as to the best treatment option for primary, steroid-resistant FSGS, Cyclosporine or Dexamethasone and MMF. How long does a patient remain in the study if their disease is not responding to the study medications?If a patient is not showing improvement in urinary protein losses after six months of study medication, study medication will be terminated and the patient will return to therapy as dictated by his or her treating nephrologist. Does a participating center need to have their consent approved by the core center prior to submission to their IRB?No. What is the IND number for this study?The IND number for this phase III study is 68,498. This applies to Neoral, Cellcept, Prinivil and Cozaar. Will there be an investigational brochure even though this is not an IND study?No. Please refer to the package insert for drug information on all study medications. Will there be an outside monitor? If so, do we know whom? And how often monitoring will occur?No. There will not be an on site review of source documents. Can a Nurse Practitioner do the physical exams?Yes. Nurse Practitioners and Fellows can also do physical exams with physician oversight. Who pays for lab shipping charges?The laboratory and shipping costs will be prepaid by the study Data Coordinating Center. Which assay is used by the central laboratory for cyclosporine levels?Whole blood. What will the turnaround time be for the lab results?1 ½ to 2 days, except Sunday. e.g.: A) a sample drawn on Monday and shipped to the central lab on Monday; B) the specimen will be analyzed on Tuesday and C) results will be faxed to centers by Wednesday at 2 am. How much blood will be drawn during the study? I need to provide this to my IRB.Spectra has provided a blood volume table [.pdf]. If the patient consents to participate to having specimens placed in the repository for future studies, additional blood will be collected If a patient transfers to another center and is continued to be followed on the study, how does the Case Report Form/study documents submission and payment schedule work? There will be a transfer form for the transferring center to complete. The reimbursement for the transferring center and new center will be prorated. The new center will also receive a transfer fee of $250. When can centers expect to see a final budget?Please contact your Core Coordinating Center for details. When can I get a subcontract for the study?The subcontract is currently being finalized by each Core Coordinating Center. Once the subcontract is finalized it will be distributed to the participating sites. Will study medications be provided free of charge?Yes, except for oral prednisone if used to treat relapse. Have dates been set for training?Participating centers are slated for training during the following months: Who is my primary contact before enrollment begins for information regarding this study?You should contact your Core Coordinating Center with any questions you might have regarding the protocol, forms, etc. If need be, your Core Coordinating Center will contact the DCC on your behalf to clarify information. When will the patient questionnaires be available? I need to give them to my IRB.Please contact your Core Coordinating Center for copies of the questionnaires. How long will a participant be followed/monitored during the study?Patient data collection will continue through final follow up data collection on December 1, 2007. This is when the study ends. The patients are on study medication for 18 months. They are will continue to be monitored until December 1, 2007. Who are the manufacturers of the drugs that will be used in the study?Cyclosporine A - Novartis Mycophenolate Mofetil - Roche Dexamethasone - Roxane Prednisone - Roxane Lisinopril - Merck Losartan - Merck I need to get my consent form translated into Spanish, who does the translation and who pays for this cost?Each participating center will need to take care of their own translations, as each center's consent forms will be different. The cost, if any, will come out of each center's reimbursement fee of $4200. I need the prototype consent form in electronic format to revise them to submit them to my IRB - where can I get a copy?You can download them here, or contact your Core Coordinating Center. I need the protocol and Case Report Forms in electronic format - where can I get a copy?You can download them here, or contact your Core Coordinating Center. Still have questions? Please submit your contact information and question(s) here:
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