November 12, 2011

Late Breaking Clinical Trials at ASN 2011 – FISH study and more

The late breaking clinical trials session from the 2011 American Society of Nephrology meeting was held on November 12, 2011.  The following are summaries of some of the clinical trial results.  Access to the full details of these studies awaits publication in peer reviewed journals.

Charmaine E. Lok et al.  The Fish Oil Inhibition of Stenosis in Hemodialysis Grafts (FISH) Study

This randomized- controlled trial compared fish oil versus placebo in primary AVG graft potency.  There was no significant difference in the primary outcome of proportion of patients with loss of native graft patency at 12 months.  However, there was a significant difference in rates of loss of patency and thrombosis.  More interestingly, however, were the results of the secondary outcomes: there was a significnat decrease in time to first cardiovascular event as well as a decrease in mean systolic blood pressure in the fish oil group.  Bleeding event rates were the same in both groups.

Judith M. Hoogendijk-van den Akker et al.  Reduced Rate of Cutaneous Squamous Cell Carcinomas after Conversion to Sirolimus-Based Immunosuppression in Stable Renal Transplant Recipients: A Randomized, Prospective, Open-Label Multicenter Study

This randomized, prospective, open-label mutlicenter study compared conventional immunosupprezsion versus a sirolimus- based regimen in stable renal transplant patients with biopsy proven cutaneous squamous cell carcinoma.  The intention to treat results showed a significant difference in the recurrence rate of developing subsequent squamous cell carcinoma (HR 0.62 (0.39 – 0.97), p = 0.038) as well a significant decrease in the total number of squamous cell carcinomas (RR 0.47 (0.29-0.76), p = 0.002).

Ashima Gulati et al.  Multicenter Randomized Controlled Trial Comparing Efficacy of Tacrolimus to Intravenous Cyclophosphamide in Children with Steroid Resistant Nephrotic Syndrome

Five centres in India participated in this trial of children with steroid resistant nephrotic syndrome defined as no response to prednisone 2 mg/kg after 4 weeks of treatment. In addition to prednisone, patients were treated with either tacrolimus or intravenous cyclophosphamide.  The primary outcome of the rate of complete or partial remission at 6 months was statistically different between the groups – 83% in the tacrolimus group vs 46% in the cyclophosphamide group (p < 0.001).  There was also a statistically significant difference in the secondary outcome of maintaining remission at 12 months in favor of the tacrolimus group (53% vs 15%, p < 0.01).  There was also less risk of treatment failure or severe infection in the tacrolimus group.

Uwe Querfeld et al.  A Randomized Cross-Over Muticenter Trial of Mycophenolate Mofetil versus Cyclosporin A in Children with Frequently Relapsing Nephrotic Syndrome

This German crossover designed study looked at children with frequently relapsing nephrotic syndrome and randomized them to 12 months of either cyclosporine or MMF.  After 12 months, they were crossovered to the other group and treated for another 12 months.  Therefore, both groups received 12 months of each agent.  The primary outcome of frequency of relapses during both years of treatment showed that cyclosporine was superior to MMF (85 % vs 64% with no relapses).  The investigators hypothesized that this was due to the lower MMF exposure and suggest that a higher MMF level should be targeted.

Ian H. de Boer et al.  Effects of Intensive Diabetes Therapy on Glomerular Filtration Rate in Type 1 Diabetes: Results from the DCCT/EDIC [Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Study]

Click here to learn more about this trial, simultaneously published online in the New England Journal of Medicine, in order to coincide with the presentation at the ASN.

Ravi I. Thadhani et al.  Vitamin D Therapy and Cardiac Structure, Function, and Cardiovascular Events.

PRIMO is an industry sponsored study designed to test whether oral paricalcitriol at 2 ug po od for 48 weeks would reduce LV hypertrophy, diastolic dysfunction, biomarkers of cardiac dysfunction, and/or cardiac events. Patients were enrolled if they had mild to moderate LV dysfunction, GFR 15-60 ml/min per 1.73 m2, and iPTH 50 to 300 ng/L.  811 patients were screened and 227 were enrolled (115 paricalcitriol; 112 placebo).  In the treatment group, iPTH reduced from to baseline level to approximately 30 ng/L but there was no signficant reduction in LVMI (left ventricular mass index). In fact, the placebo group tended to have a lower LVMI than the treatment group. Diastolic dysfuncion and biomarkers were also not difference. Of note, there were fewer cardiac events in the treatment group (1 vs 8) which reached statistical signficance (p=0.034).

Related Articles:

Bone Mineral Metabolism, Clinical Trial Results, General Nephrology, Glomerulonephritis, Pediatric Nephrology, Renal Transplantation, Vascular Access

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