A new peritoneal dialysis fluid for Japan: A randomized non-inferiority clinical trial of safety and efficacy

ISRCTN ISRCTN10007426
DOI https://doi.org/10.1186/ISRCTN10007426
Secondary identifying numbers BLR250-01
Submission date
02/02/2016
Registration date
08/03/2016
Last edited
25/04/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Chronic kidney disease (CKD) is a long-term condition where the kidneys do not work properly. In a healthy person, the kidneys are responsible for filtering out the waste products and excess water in the blood, and converting them into urine. In patients suffering from CKD, the kidneys are unable to do this, and so the body is unable to get rid of the waste products building up in the blood. There are a number of treatments available which act to replace the function of the kidneys. One technique used is continuous ambulatory peritoneal dialysis (CAPD). This type of treatment is normally repeated between three and five times day, and is very popular as it can be done at home or work while the patient goes about their daily life. In this technique, the thin membrane (lining) that lines the peritoneal cavity (space in the abdomen that separates the organs from the abdominal wall) acts as a natural filter. It involves filling the abdominal cavity with a special fluid (dialysate) which is left to absorb waste products before being drained away. The dialysate used for CAPD contains different concentrations of sugars and salts and different amounts of waste are filtered out of the body depending on the concentrations used. It has been found that the concentrations of different mineral salts (particularly magnesium and calcium) in some dialysates can react in the body to produce high levels of bicarbonate in the blood. Biocarbonate is important for maintaining the pH of the blood (preventing it from becoming too acidic or alkaline) but if levels are too high (metabolic alkalosis) it can lead to dangerous consequences. A possible solution is a by using a double-chambered bag, such as with the product BLR250 which keeps bicarbonate separate from calcium and magnesium in order to prevent the creation of more bicarbonate. The aim of this study is to test the safety of using BLR250 for CAPD and to find out if it can prevent metabolic alkalosis.

Who can participate?
CKD patients over 20 years old who have been treated using CAPD for at least 3 months.

What does the study involve?
Participants are randomly allocated to one of two groups. For those in group one, each time the CAPD procedure is done, 2L of BLR250 is used as the dialysate fluid. For group two, each time the CAPD procedure is done, 2L of Dianeal PD-4 (normal dialysate solution) is used as the dialysate fluid. Participants in both groups use their assigned dialysate every time they dialyse for 8 weeks. At the start of the study, and then again after 4, 8 and 12 weeks, participants have a blood test in order to measure how well the dialysis is working at replacing kidney function, and to have the amounts of bicarbonates and different minerals in the blood measured.

What are the possible benefits and risks of participating?
Participants may benefit from a lower blood bicarbonate level. There are no risks for participants taking part in the study as the techniques used in the study are treatments that are already offered in standard practice, although some participants may experience pain or bruising when having blood taken.

Where is the study run from?
24 hospitals in Japan.

When is the study starting and how long is it expected to run for?
March 2003 to March 2004

Who is funding the study?
Baxter Limited (Japan)

Who is the main contact?
Mr Shohi Saraya

Contact information

Mr Shoji Saraya
Scientific

Toranomon Hills Mori Tower 20F
1-23-1, Toranomon
Minato-ku
Tokyo
105-6320
Japan

Study information

Study designProspective randomized parallel trial
Primary study designInterventional
Secondary study designRandomised parallel trial
Study setting(s)Home
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet.
Scientific titleA randomized parallel-group comparative study to verify efficacy (non-inferiority) of BLR250 using Dianeal PD-4 as a comparator in patients with chronic renal failure receiving CAPD (Continuous Ambulatory Peritoneal Dialysis)
Study objectivesTo verify the efficacy (non-inferiority) and safety of BLR250 using Dianeal PD-4 as a comparator in patients with chronic renal failure receiving CAPD therapy.
Ethics approval(s)Institutional Review Board, Baxter Limited (Japan), 23/07/2002
Health condition(s) or problem(s) studiedChronic renal failure
InterventionParticipants fulfilling the eligibility are randomly allocated into one of two arms.

Active treatment arm: Each participant is given BLR250 to use as their peritoneal dialysate for a total of 8 weeks. The process is repeated between 3 and 5 times every day as required, using a total of 2L dialysate at each exchange.

Control treatment arm: Each participant is given Dianeal PD-4 to use as their peritoneal dialysate for a total of 8 weeks. The process is repeated between 3 and 5 times every day as required, using a total of 2L dialysate at each exchange.

All participants are followed up at 4 weeks.
Intervention typeDrug
Pharmaceutical study type(s)
PhasePhase III
Drug / device / biological / vaccine name(s)1. BLR250 2. Dianeal PD-4
Primary outcome measurePeritoneal creatinine clearance and ultrafiltration volume are measured using blood and dialysis effluent analysis at baseline, 4, 8 and 12 weeks.
Secondary outcome measures1. Peritoasuneal urea clearance is measured using blood and dialysis effluent analysis at baseline, 4, 8 and 12 weeks
2. Electrolyte (Na, K, Cl, Ca, Mg, P) concentration is measured using blood analysis at baseline, 4, 8 and 12 weeks
3. Plasma bicarbonate concentration is measured using blood analysis at baseline, 4, 8 and 12 weeks
Overall study start date24/03/2003
Completion date18/03/2004

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants50 patients in Arm 1 and 58 patients in arm 2 are enrolled.
Total final enrolment108
Key inclusion criteria1. Patients that have been continuously undergoing CAPD therapy for at least 3 months before the start of the baseline period
2. Patients that have been continuously using solely 2 L of Dianeal PD-4 for at least 4 weeks before the start of the baseline period
3. Patients that have given written consent to participate in this study
4. Patients that are aged over 20 years at the time of giving consent
Key exclusion criteria1. Patients that have a tunnel infection or a severe exit-site infection and are likely to develop peritonitis
2. Patients that have developed peritonitis or have not recovered from peritonitis within 4 weeks before the start of the baseline period
3. Patients with a serious disease other than chronic renal failure (e.g., malignant tumor, hepatic cirrhosis, active hepatitis, chronic heart failure, systemic infection, significant malnutrition, significant peritoneal membrane dysfunction, negative ultrafiltration and likely to convert to hemodialysis)
4. Patients that have participated in another clinical study within 6 months before obtaining consent
5. Patients that are pregnant, lactating or may be pregnant
6. Patients that have been judged to be ineligible to participate in this study by the investigator/sub-investigator
Date of first enrolment24/03/2003
Date of final enrolment28/11/2003

Locations

Countries of recruitment

  • Japan

Study participating centres

Asahikawa Red Cross Hospital
070-8530
Japan
Sendai Social Insurance Hospital
981-8501
Japan
Tokyo Jikei-kai Medical School Hospital
105-8471
Japan
Tokyo Jikei-kai Medical School Kashiwa Hospital
277-8567
Japan
Mitsui Memorial Hospital
101-8643
Japan
Nihon University Itabashi Hospital
173-8610
Japan
St. Marianna University School of Medicine Hospital
216-8511
Japan
Hospital Affiliating with Kanagawa Prefecture Nursing School
235-0022
Japan
Showa University Fujigaoka Hospita
227-8501
Japan
Aichi Medical University Hospital
480-1195
Japan
Chukyo Hospita
457-8510
Japan
Clinic affiliating with Inoue Hospital
564-0053
Japan
Kinki University School of Medicine Hospital
589-8511
Japan
Osaka Koseinenkin Hospital
553-0003
Japan
Hiroshima University Hospital
734-8551
Japan
Tokushima Red Cross Hospital
773-8502
Japan
Saiseikai Yahata General Hospital
805-0050
Japan
Shizuoka Genaral Hospital
420-8527
Japan
Shirasagi Clinic
546-0002
Japan
Osaka City University School of Medicine Hospital
545-8586
Japan
Teine Keijinkai Hospital
006-8555
Japan
Tokai University School of Medicine Hospital
259-1193
Japan
Tokuyama Central Hospital
745-8522
Japan
Hakodate Goryoukaku Hospital
040-8611
Japan
Kawasaki Medical School Hospital
701-0192
Japan
Saiseikai Central Hospital
108-0073
Japan
Tokyo Kyosai Hospital
153-8934
Japan
Kumamoto Central Hospital
862-0965
Japan

Sponsor information

Baxter Limited
Industry

Toranomon Hills Mori Tower 20F
1-23-1, Toranomon
Minato-ku
Tokyo
105-6320
Japan

Website http://www.baxter.co.jp
ROR logo "ROR" https://ror.org/02d6ew870

Funders

Funder type

Industry

Baxter Limited

No information available

Results and Publications

Intention to publish date31/07/2016
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planPlanned publication in Clinical and Experimental Nephrology.
IPD sharing planThe datasets generated during and/or analysed during the current study are not expected to be made available

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 25/10/2016 25/04/2023 Yes No

Editorial Notes

25/04/2023: Publication reference and total final enrolment added.