, 5 and the LJP 394-90-09 Investigator ConsortiumObjective. To investigate whether treatment with abetimus delays renal flare in patients with lupus nephritis. Secondary objectives included evaluation of the effect of abetimus on C3 levels, anti-doublestranded DNA (anti-dsDNA) antibody levels, use of high-dose corticosteroids and/or cyclophosphamide, and major systemic lupus erythematosus (SLE) flare.Methods. We conducted a randomized, placebocontrolled study of treatment with abetimus at 100 mg/week for up to 22 months in SLE patients. Three hundred seventeen patients with a history of renal flare and anti-dsDNA levels >15 IU/ml were randomized to a treatment group (158 abetimus, 159 placebo); 298 (94%) were enrolled in the intent-to-treat ( Abetimus treatment decreased anti-dsDNA antibody levels (P < 0.0001), and reductions in anti-dsDNA levels were associated with increases in C3 levels (P < 0.0001). More patients in the abetimus group experienced >50% reductions in proteinuria at 1 year, compared with the placebo group (nominal P ؍ 0.047). Trends toward reduced rates of renal flare and major SLE flare were noted in patients treated with abetimus who had impaired renal function at baseline. Treatment with abetimus for up to 22 months was well tolerated.Conclusion. Abetimus at 100 mg/week significantly reduced anti-dsDNA antibody levels but did not significantly prolong time to renal flare when compared with placebo. Multiple positive trends in renal end points were observed in the abetimus treatment group.There is a substantial body of evidence implicating anti-double-stranded DNA (anti-dsDNA) antibodies in the pathogenesis of lupus nephritis. Anti-dsDNA antibodies are rarely found in individuals without SLE (1-4), and their presence is diagnostic for SLE and prognostic for development of lupus nephritis. The presence of anti-dsDNA antibodies often correlates with active renal disease (5-8). Anti-dsDNA antibodies are concentrated in the kidneys of SLE patients and often have a much higher avidity for dsDNA than do antibodies in the circulation (9,10). Well-controlled studies have demonstrated a strong correlation between rises in anti-dsDNA antibody levels and subsequent exacerbations of . Similarly, reductions in antiClinicalTrials.gov identifier: NCT00035308.
Prolonged cold ischaemic time (CIT) is associated with delayed initial graft function and may also have a negative impact on long-term graft outcome. We carried out a study comparing the long-term graft survival rates between those recipients who received the first of a pair of donor kidneys versus the recipient of the second graft.Adult kidney transplant recipients who received one of a pair of donor kidneys at our institution between 1989-1995 were included. All recipients received a cyclosporin based immunosupression regimen. Graft survival rates were compared between the 2 groups at 1-, 3-, 5-and 10-year intervals. A total of 520 renal transplant grafts were included in this study. Mean donor age was 35.4 years. Groups were similar for recipient age, gender, number of HLA mismatches, transplant number for that patient and percentage PRA. CIT was the only variable that was significantly different between the two groups; mean of 19.93 h in the first group compared to 25.65 h in the second group. Graft survival rates for the first kidney were significantly better than the second kidney-graft survival at 1 year 88.5% versus 84.7%, at 3 years 81.8% versus 76.7%, at 5 years 72.2% versus 64.9% and at 10 years 55.2% versus 40% (p = 0.012). Patient survival rates were similar in both groups.In our experience, the long-term graft survival rates are significantly better for the first kidney transplanted compared to the second kidney.
1 The pharmacokinetics of enalaprilat were studied after administration of single and multiple doses of enalapril maleate to people with normal and impaired renal function. 2 Renal impairment was associated with higher serum concentrations of enalaprilat, longer times to peak concentrations, slower decline of serum concentrations and with reduced urinary elimination. Urinary elimination of enalaprilat was closely related to renal function.3 In patients with severe renal impairment (GFR values below 30 ml min7l 1.73 m-2) significantly smaller doses of enalapril maleate will be required than in patients with normal or less severely impaired renal function.
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