title: A new peritoneal dialysis fluid for Japanese patients: a randomized non-inferiority clinical trial of safety and efficacy.
abstract: BACKGROUND
  We report here two new peritoneal dialysis fluids (PDFs) for Japan [BLR 250, BLR 350 (Baxter Limited, Japan)]. The PDFs use two-chamber systems, and have bicarbonate and lactate buffer to a total of 35 mmol/L. In separate trials, the new PDFs were compared to two "standard" systems [PD-4, PD-2 (Baxter Limited, Japan)]. The trials aimed to demonstrate non-inferiority of peritoneal creatinine clearance (pCcr), peritoneal urea clearance (pCurea) and ultrafiltration volume (UF), and compare acid-base and electrolyte balance.
  
  
  METHODS
  We performed randomized, multicenter, parallel group, controlled, open-label clinical trials in stable continuous ambulatory peritoneal dialysis (CAPD) patients. The primary endpoints were pCcr and UF. The secondary endpoints were serum bicarbonate and peritoneal urea clearance. The active phase was 8 weeks. These trials were performed as non-inferiority studies, with the lower limit of non-inferiority for pCcr and UF set at 3.2 L/week/1.73 m2and 0.12 L/day, respectively.
  
  
  RESULTS
  108 patients (28 centers) and 103 patients (29 centers) took part in the two trials. Groups were well balanced at baseline. The investigative PDFs were non-inferior to the "standard" ones in terms of primary endpoints, comparable in terms of pCurea, and superior in terms acid-base balance, especially correcting those with over-alkalinization at baseline.
  
  
  CONCLUSIONS
  We demonstrated fundamental functionality of two new PDFs and showed superior acid-base balance. Given the propensity of Japanese CAPD patients for alkalosis, it is important to avoid metabolic alkalosis which is associated with increased cardiovascular mortality risk and accelerated vascular calcification. The new PDFs are important progress of CAPD treatment for Japanese patients.
authors: Department of Nephrology and Hypertension, School of Medicine, Fukushima Medical University, Fukushima, Japan.|Department of Internal Medicine, Nephrology and Hypertension, Tokyo Jikei-kai Medical School, Tokyo, Japan.
authors: Masaaki
authors: M
authors: Nakayama
authors: Hospital Affiliating with Kanagawa Prefecture Nursing School, Isehara, Kanagawa, Japan.
authors: Yoshindo
authors: Y
authors: Kawaguchi
authors: Sekikawa Hospital, Tokyo, Japan.|Department of Blood Purification, Tokyo Women's Medical University, Tokyo, Japan.
authors: Takashi
authors: T
authors: Akiba
authors: Kaikou Clinic, Osaka, Japan.|Osaka Dialysis Department, Kaiko-Kai Clinic, Osaka, Japan.
authors: Masao
authors: M
authors: Kim
authors: Naito Medical Research Laboratory, Kobe, Hyogo, Japan.|Hakubi-kai, Sano Ikawadani Hospital, Kobe, Hyogo, Japan.
authors: Hidemune
authors: H
authors: Naito
authors: Hara Press Center Clinic, Tokyo, Japan.|Kidney Center, Toranomon Hospital, Tokyo, Japan.
authors: Shigeko
authors: S
authors: Hara
authors: Asao Kidney Clinic, Kawaski, Kanagawa, Japan.|Department of Internal Medicine, Nephrology and Hypertension, St. Marianna University School of Medicine, Kawaski, Kanagawa, Japan.
authors: Teruhiko
authors: T
authors: Maeba
authors: Hiroshima Kidney Organization, Hiroshima, Japan.|Department of Molecular and Internal Medicine, Graduate School of Biomedical Sciences, Hiroshima University, Hiroshima, Japan.
authors: Noriaki
authors: N
authors: Yorioka
authors: Therapeutic Area, Baxter Healthcare Corporation, Deerfield, IL, USA.
authors: James A
authors: JA
authors: Sloand
authors: Therapeutic Area, Baxter Healthcare (Asia) Pte Ltd, Singapore, Singapore. mark_roger_marshall@baxter.com.|School of Medicine, Faculty of Medical and Health Sciences, University of Auckland, Parnell, PO Box 37968, Auckland, 1151, New Zealand. mark_roger_marshall@baxter.com.
authors: Mark R
authors: MR
authors: Marshall
mesh_terms: D000136:Acid-Base Equilibrium; D000328:Adult; D000368:Aged; D000471:Alkalosis / Q000209:etiology / Q000517:prevention & control; D001639:Bicarbonates / Q000009:adverse effects / Q000627:therapeutic use*; D002021:Buffers; D003404:Creatinine / Q000378:metabolism; D015314:Dialysis Solutions / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007564:Japan; D019344:Lactic Acid / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010531:Peritoneal Dialysis, Continuous Ambulatory / Q000009:adverse effects / Q000379:methods*; D010537:Peritoneum / Q000378:metabolism; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D001639:Bicarbonates; D002021:Buffers; D015314:Dialysis Solutions; D019344:Lactic Acid; D003404:Creatinine
keywords: Biocompatibility; Dialysis adequacy; Metabolic alkalosis; Peritoneal dialysis