Effect of Chelation Therapy on Progressive Diabetic Nephropathy in Patients With Type 2 Diabetes and High-Normal Body Lead Burdens
American Journal of Kidney Diseases, 06/22/2012
Chen KH et al. – A 27–month course of EDTA chelation therapy retards the progression of diabetic nephropathy in type 2 diabetic patients with high–normal body lead burdens.Methods
- A 12-month run-in phase, then a randomized single-blind study with a 27-month intervention.
- University medical center; 50 patients (serum creatinine, 1.5-3.9 mg/dL) with high-normal body lead burden (≥80-<600 μg) were randomly assigned to the treatment and control groups.
- The treatment group received weekly chelation therapy for 3 months to reduce their body lead burden to <60 μg and then as needed for 24 months to maintain this level.
- The control group received placebo for 3 months and then weekly for 5 weeks at 6-month intervals for 24 months.
- The primary end point was change in estimated glomerular filtration rate (eGFR) over time.
- A secondary end point was a 2-fold increase in baseline serum creatinine level or the requirement for renal replacement therapy.
- Body lead burdens were assessed by EDTA mobilization tests and eGFR was calculated using the equation for Chinese patients with type 2 diabetes.
- Mean baseline eGFRs in the treatment and control groups were similar.
- After 3 months of chelation therapy, the change in eGFR in the treatment group (+1.0±4.8 mL/min/1.73 m2) differed significantly from that in the control group (-1.5±4.8 mL/min/1.73 m2; P = 0.04).
- In the subsequent 24-month intervention, the yearly rate of decrease in eGFR (5.6±5.0 mL/min/1.73 m2 per year) in the treatment group was slower than that (9.2±3.6 mL/min/1.73 m2 per year; P = 0.04) in the control group. 17 (68%) control-group patients and 9 (36%) treatment-group patients achieved the secondary end point.