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INFORMATION FOR PATIENTS
FAQs for Potential PatientsWhat is the FSGS study?Focal Segmental Glomerulosclerosis (FSGS) is a disease that causes scarring of the glomeruli, which are the filtering units of the kidney. This scarring causes kidneys to lose protein in the urine (proteinuria) and reduces your kidneys' ability to function. You are invited to participate if you have FSGS and you have already taken medicine (corticosteroids such as prednisone) to decrease the amount of protein in your urine. If this therapy has not worked for you, you may qualify for this study. Why is this research study being done?The aim of this study is to treat FSGS with two different methods to see which method works best in stopping the damage FSGS does to your kidneys. One will use a medication called Cyclosporine (CSA). The other will use two medicines called Mycophenolate Mofetil (MMF) and a corticosteroid called Dexamethasone. The medicines being used in this study are already being given to treat patients with FSGS. If you decide not to be part of the study, your doctor may recommend one of these treatments anyway. Experts disagree as to what the best treatment is, which is why we are doing this study. We want to see what works best in treating FSGS. Are there benefits to taking part in the study?There may or may not be a direct medical benefit to a you. Benefits could include decreasing proteinuria, increasing protein in your blood, and decreasing or stopping swelling. This study may also benefit future patients by showing us which of these two treatments treat patients with FSGS best. You may receive no benefit from participating in the study. Your urine protein may increase, stay the same, or decrease while on the study medications. You may also experience adverse effects from the study drugs as well. How many people will take part in the study?About 200 children and adults around the United States (ages 2-40) will take part in the study. All will have proteinuria and a kidney biopsy showing they have FSGS. How long does it take to complete the study?If you remain until completion, you will be seen regularly for 78 weeks. After that time, you will be monitored every six months until the end of the study. Will I have to pay for any visits, tests or medications?Neither you nor your insurance company will be charged for taking part in this study. The sponsor of this research, the National Institutes of Health, will pay for the costs of the study. This includes costs of study medications, laboratory tests, and visits. Will I be paid to participate in this study?You will not be paid to take part in this study. However, your study site may pay you a nominal fee to reimburse you for costs such as transportation, meals, or childcare that is needed in order to make your study visits. Please check with your study site for additional details. If I participate and become ill during the study, who should I call?You may first call your study coordinator/doctor, or you may call your regular doctor to discuss your illness. They may tell you to visit the office for evaluation. Keep a log of any illness you may experience so you can tell the doctor at your next study visit. Does MMF have any side effects? Has it been used before in FSGS patients?MMF has been used in small numbers of patients with FSGS and appears to have helped some of them. However, most of our information about side effects with MMF come from its use in transplant patients. The most common side effects with MMF are diarrhea, low white blood cell counts, sepsis (infection in the blood) and vomiting. There is also evidence of a higher frequency of certain types of infections. What about CSA... are there any side effects?CSA is a medicine that weakens the immune system and has been used for years in children who have organ transplants. The risks of taking CSA include: decreased kidney function, trembling of the hands, increased hair growth, high blood pressure, increased size of your gums, increase in blood potassium (which can cause heart rhythm disturbances), and decreases in blood magnesium, which may cause twitching or seizures. What are the side effects of Prednisone and Dexamethasone (DEXA)?These are medications that belong to the group of drugs know as "steroids". All patients will receive a low dose of prednisone by mouth every other day for the first 6 months of the study. Patients in the Dexamethasone group will take Dexamethasone over a period of one year. Side effects that may occur in patients on these medications include: lowered serum potassium (may cause muscle weakness), loss of muscle mass, loss of bone mass (osteoporosis), increased blood pressure, headache, increase in behavioral and psychiatric problems, increase in facial fat particularly around the cheeks, decrease in growth, decrease in the body's own steroid production, increase in blood sugar, increase in hair growth, increase in appetite, weight gain, and nausea. What should I know about Lisinopril?Lisinopril is a drug that controls blood pressure and has been shown to decrease the protein in the urine. The dose of lisinopril you will take is based on your weight and blood pressure. Side effects of lisinopril may include: headache, dizziness, and cough. Rarely, a condition known as angio-edema has occurred. This causes swelling of the face, lips, tongue, and the larynx (voice box) such that difficulty in breathing may develop. Without treatment, this side effect can lead to death. If lisinopril does not control your blood pressure or if you have side effects, other drugs are prescribed. Pregnancy and birth control during the study: The medications being used in this study should not be used in pregnant women. Effective contraception must be used before beginning therapy and during therapy. In this study, contraception will be continued until the patient is off lisinopril at the 78-week visit (Visit 15). I would like to contact the Study Investigators to see if I can participate.Please choose the study site nearest you. Participating Centers> Still have questions? Please submit your question here:
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