A randomized crossover trial comparing sevelamer with calcium acetate in children with CKD.
BACKGROUND
A multicenter, randomized, open-label, crossover study was performed to compare the efficacy and safety of sevelamer, a calcium-free phosphate binder, with calcium acetate in pediatric patients with chronic kidney disease (CKD).


METHODS
Children (age, 0.9 to 18 years) with CKD undergoing hemodialysis or peritoneal dialysis or with a glomerular filtration rate of 20 or greater and less than 60 mL/min/1.73 m2 (> or = 0.33 and < 1.00 mL/s/1.73 m2) were randomly assigned to the following treatment scheme: 2 weeks of washout followed by 8 weeks of treatment with either sevelamer or calcium acetate in a crossover fashion. Phosphorus, calcium, and intact parathyroid hormone in serum were measured every 2 weeks, and phosphate binder dosages were adjusted, if needed. Serum lipid and vitamin concentrations were measured at the beginning and end of each treatment period. The primary end point was the decrease in serum phosphorus levels after 8 weeks of treatment.


RESULTS
Forty-four patients were screened. Altogether, data for 18 patients (5 girls) aged 12.4 +/- 4.1 years were used for the crossover analysis. There was no significant difference in serum phosphorus levels at 8 weeks after the start of treatment in both groups. Total cholesterol (-27%) and low-density lipoprotein cholesterol (-34%) levels decreased significantly with sevelamer treatment (P < 0.02 and P < 0.005). An increased incidence of hypercalcemia (P < 0.0005) was observed with calcium acetate treatment, whereas metabolic acidosis was more frequent with sevelamer treatment (P < 0.005).


CONCLUSIONS
Treatment of children with CKD with sevelamer and calcium acetate provides similar phosphorus level control. The marked decrease in lipid levels and lower rate of hypercalcemia may augment the long-term benefit of sevelamer.
Pieper
Anne-Kathrin
AK
Department of Pediatric Nephrology, Charité, Humboldt University, Berlin, Germany.
Haffner
Dieter
D
Hoppe
Bernd
B
Dittrich
Katalin
K
Offner
Gisela
G
Bonzel
Klaus-Eugen
KE
John
Ulrike
U
Fründ
Stefan
S
Klaus
Günter
G
Stübinger
Amrey
A
Düker
Gesche
G
Querfeld
Uwe
U
D000085:Acetates / Q000627:therapeutic use*; D000293:Adolescent; D017610:Calcium Compounds; D002648:Child; D002675:Child, Preschool; D002908:Chronic Disease; D018592:Cross-Over Studies; D005260:Female; D006801:Humans; D007223:Infant; D007674:Kidney Diseases / Q000188:drug therapy*; D008297:Male; D011073:Polyamines / Q000627:therapeutic use*; D000069603:Sevelamer
D000085:Acetates; D017610:Calcium Compounds; D011073:Polyamines; D000069603:Sevelamer; C120662:calcium acetate