Clinical Trials

• Hypertension
• Renal disease in sickle cell anemia
• Diabetic nephropathy
• Glomerulonephritis
• Polycystic kidney disease
• Hemodialysis access failure
• Lupus nephritis
• Heart disease in renal failure

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Hypertension

African-American Study of Kidney Disease and Hypertension Trial (AASK); Principal Investigator: Janice Lea, MD

The AASK trial is a multicenter NIH trial with 1,000 patients nationwide who are African-American between the ages of 18 and 65 with mild to moderate kidney failure due to hypertension. The study is investigating whether treatment with specific antihypertensive medications and/or aggressive lowering of blood pressure will be of benefit in slowing the progression of kidney failure. The study is currently closed to enrollment. Dr. Janice Lea is a clinical specialist in hypertension designated by the American Society of Hypertension and sees a variety of difficult hypertensive cases in her clinic.

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Sickle Cell Nephropathy

Mechanisms of Glomerular Damage in Sickle Cell Anemia;
Principal Investigator: Antonio Guasch, MD

Kidney damage occurs commonly in patients with sickle cell anemia and, in some patients, it could lead to kidney failure. Unfortunately, when blood tests indicate kidney problems, the kidney damage is usually very extensive and often irreversible. We are studying ways, using simple urine sample tests, to detect early kidney damage in sickle cell anemia and testing new treatments for people with this condition. These studies, aimed at helping patients with sickle cell anemia and kidney trouble, are conducted in the Sickle Cell Clinic at Grady Memorial Hospital and at the Emory Clinical Research Center.

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Diabetic Nephropathy

Effect of Antihypertensive Therapy on the Progression of Diabetic Kidney Disease;
Principal Investigator: Antonio Guasch, MD

Kidney damage occurs very frequently in people who suffer from diabetes and may lead to kidney failure, requiring dialysis or transplantation. The currently available treatments slow down kidney deterioration, but do not completely stop the ongoing kidney damage. We are testing new treatments for people who suffer from diabetes and kidney damage with the goal of preventing the development of kidney failure.

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Glomerulonephritis

Novel Antiinflammatory Therapies for Glomerulonephritis;
Principal Investigator: Antonio Guasch, MD

...... Glomerulonephritis is a common condition that is caused by inflammation in the kidneys, resulting in kidney damage and, in some patients, in kidney failure. Although there is treatment available for some types of glomerulonephritis, the treatment may cause significant side effects. Unfortunately, some types of glomerulonephritis do not respond to currently available treatment. We are studying new, and potentially less toxic, treatments for patients who suffer from glomerulonephritis in order to control the underlying inflammation and hopefully prevent kidney failure.

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Hemodialysis Access Failure

Prevention of AV Graft Failure by Dietary N-3 Fatty Acids;
Principal Investigator: James A. Tumlin

This is a two phase trial that is designed to investigate whether dietary Omega-3 fatty acids found in fish oil is able to prevent PTFE dialysis graft from prematurely thrombosing. Previous studies have demonstrated that Omega-3 fatty acids prevent the activation of platelets as well as inhibiting release of Platelet Derived Growth Factor (PDGF). We are questioning whether patients whose diets are supplemented with Omega-3 fatty acids have lower platelet deposition along a dialysis graft. The second phase of the study will be to randomize patients to placebo or a fixed dose of fish oil; namely, 0.1 or 0.3 mg/kg/day and determine whether Omega-3 fatty acids can reduce the rate of AV graft thrombosis at one year. Admission Criteria:

• Chronic hemodialysis patient having a functional PTFE or Bovine Umbilical Vein access.

• Patients cannot be on coumadin, aspirin or other antiplatelet agents.

Duration of Study: 3 months

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Lupus Nephritis

Recurrent Lupus Nephritis: Efficacy of LJP-394 and Clone-Specific Deletion of DNA antibody Producing B Cell;
Principal Investigator: James A. Tumlin

A multicenter randomized, placebo controlled trial of LJP-394 in the prevention of recurrent lupus nephritis. LJP-394 is a B cell specific tolerogen that binds to DNA antibody producing B cells and induces antigen-specific tolerance. The rational of the study is that a growing body of clinical and experimental evidence indicates that DNA antibodies are not only good markers of Lupus activity, but also participate in the pathogenesis of Lupus Nephritis. This trial is designed to determine whether long-term reduction of Double stranded DNA antibodies reduces the incidence of Lupus Nephritis. Admission Criteria:

• Biopsy proven: WHO class III, IV, or V Lupus nephritis
• Double strand DNA antibodies greater than 15 by the Farr assay
• Prednisone dose < 20 mg
• Imuran dose < 150 mg
• Mycophenolate dose< 2000 mg
• No cyclophosphamide for 4 months prior to receiving LJP-394

Duration of Study: 2 years

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Heart Disease in Kidney Failure

Cerivastatin Heart Outcomes in Renal Disease: Understanding Survival (CHORUS) Trial;
Principal Investigator: James A. Tumlin

A multicenter, placebo-controlled trial comparing the efficacy of Cerivastatin to Placebo in preventing the development of myocardial disease in patients on dialysis less that 1 year. The rational of the study is that previous studies have shown that uremia and chronic hemodialysis accelerates coronary atherosclerotic heart disease (CASHD). To determine whether prophylactic use on HMG-Co A reductase inhibitors reduce the incidence of CASHD in patients newly started on hemodialysis and no prior heart disease. Admission Criteria:

• Hemodialysis Patient for 60 days to one year
• No known CASHD
• Ejection fraction >35%
• No previous HMG CoA reductase therapy within 1 year of study
• No patients with HIV