1.
Ferric pyrophosphate citrate administered via dialysate reduces erythropoiesis-stimulating agent use and maintains hemoglobin in hemodialysis patients
Gupta A, Lin V, Guss C, Pratt R, Ikizler TA, Besarab A
Kidney International. 2015;88((5)):1187-94.
Abstract
Ferric pyrophosphate citrate (FPC) is a water-soluble iron salt administered via dialysate to supply iron directly to transferrin. The PRIME study tested whether treatment with FPC could reduce prescribed erythropoiesis-stimulating agent (ESA) use and maintain hemoglobin in hemodialysis patients. This 9-month, randomized, placebo-controlled, double-blind, multicenter clinical study included 103 patients undergoing hemodialysis 3-4 times weekly. The FPC group received dialysate containing 2mumol/l of iron. The placebo group received standard dialysate. A blinded central anemia management group facilitated ESA dose adjustments. Intravenous iron was administered according to the approved indication when ferritin levels fell below 200mug/l. The primary end point was the percentage change from baseline in prescribed ESA dose at end of treatment. Secondary end points included intravenous iron use and safety. At the end of treatment, there was a significant 35% reduction in prescribed ESA dose in FPC-treated patients compared with placebo. The FPC patients used 51% less intravenous iron than placebo. Adverse and serious adverse events were similar in both groups. Thus, FPC delivered via dialysate significantly reduces the prescribed ESA dose and the amount of intravenous iron needed to maintain hemoglobin in chronic hemodialysis patients.
2.
Optimization of epoetin therapy with intravenous iron therapy in hemodialysis patients
Besarab A, Amin N, Ahsan M, Vogel SE, Zazuwa G, Frinak S, Zazra JJ, Anandan JV, Gupta A
Journal of the American Society of Nephrology. 2000;11((3):):530-8.
Abstract
Iron deficiency limits the efficacy of recombinant human erythropoietin (rhEPO) therapy in end-stage renal disease (ESRD) patients. Functional iron deficiency occurs with serum ferritin >500 ng/ml and/or transferrin saturation (TSAT) of 20 to 30%. This study examines the effects of a maintenance intravenous iron dextran (ivID) protocol that increased TSAT in ESRD hemodialysis patients from conventional levels of 20 to 30% (control group) to those of 30 to 50% (study group) for a period of 6 mo. Forty-two patients receiving chronic hemodialysis completed a 16- to 20-wk run-in period, during which maintenance ivID and rhEPO were administered in amounts to achieve average TSAT of 20 to 30% and baseline levels of hemoglobin of 9.5 to 12.0 g/dl. After the run-in period, 19 patients randomized to the control group received ivID doses of 25 to 150 mg/wk for 6 mo. Twenty-three patients randomized to the study group received four to six loading doses of ivID, 100 mg each, over a 2-wk period to achieve a TSAT >30% followed by 25 to 150 mg weekly to maintain TSAT between 30 and 50% for 6 mo. Both regimens were effective in maintaining targeted hemoglobin levels. Fifteen patients in the control group and 17 patients in the study group finished the study in which the primary outcome parameter by intention to treat analysis was the rhEPO dose needed to maintain prestudy hemoglobin levels. Maintenance ivID requirements in the study group increased from 176 to 501 mg/mo and were associated with a progressive increase in serum ferritin to 658 ng/ml. Epoetin dose requirements for the study group decreased by the third month and remained 40% lower than for the control group, resulting in an overall cost savings in managing the anemia. Secondary indicators of iron-deficient erythropoiesis were also assessed. Zinc protoporphyrin did not change in either group. Reticulocyte hemoglobin content increased only in the study group from 28.5 to 30.1 pg. It is concluded that maintenance of TSAT between 30 and 50% reduces rhEPO requirements significantly over a 6-mo period.
3.
Role of preoperative donor-specific transfusion and cyclosporine in haplo-identical living related renal transplant recipients
Sharma RK, Rai PK, Kumar A, Kumar P, Gupta A, Kher V, Agrawal S, Bhandari M
Nephron. 1997;75((1):):20-4.
Abstract
A prospective randomized trial of use of donor-specific transfusion and cyclosporine given 24 h before operation was performed in living related renal transplant recipients. The benefits, disadvantages and effect on graft and patient outcome was analyzed. Cyclosporine was started 72 h before operation and 48 h before donor-specific transfusion (DST). Fifteen patients received DST while another 15 age- and sex-matched living related renal allograft recipients on similar immunosuppression served as controls. Patient and donor demographics were similar in the two groups. The DST group had significantly fewer rejection episodes than the control group (0.26 vs. 1.1 rejection episode per patient, p < 0.01). There were fewer episodes of acute rejection in the first 3 months posttransplant in the DST group. Hyperresponder recipients (as tested by mixed lymphocyte cultures) also benefitted by DST which significantly reduced the number of acute rejection episodes (0.25 vs. 1 episode per hyperresponder patient, DST vs. control, p < 0.05). The need for dialysis, incidence of infections and other complications were similar in the two groups. Graft function at 3, 6, 9 and 12 months after transplant was significantly better in the DST group (p < 0.05). Graft survival at 1 year in DST group (85.5%) was not statistically different than control (74.8%). In conclusion, DST and cyclosporine given 24 h before live related renal transplantation is effective in improving graft function and reducing the number of acute rejection episodes which could have a beneficial effect on long-term graft survival.