Plain English Summary
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
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
BLR250-01
Study information
Scientific title
A 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)
Acronym
Study hypothesis
To 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
Institutional Review Board, Baxter Limited (Japan), 23/07/2002
Study design
Prospective randomized parallel trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Home
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet.
Condition
Chronic renal failure
Intervention
Participants 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 type
Drug
Phase
Phase III
Drug names
1. BLR250
2. Dianeal PD-4
Primary outcome measure
Peritoneal creatinine clearance and ultrafiltration volume are measured using blood and dialysis effluent analysis at baseline, 4, 8 and 12 weeks.
Secondary outcome measures
1. 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 trial start date
24/03/2003
Overall trial end date
18/03/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50 patients in Arm 1 and 58 patients in arm 2 are enrolled.
Participant exclusion criteria
1. 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
Recruitment start date
24/03/2003
Recruitment end date
28/11/2003
Locations
Countries of recruitment
Japan
Trial participating centre
Asahikawa Red Cross Hospital
070-8530
Trial participating centre
Sendai Social Insurance Hospital
981-8501
Trial participating centre
Tokyo Jikei-kai Medical School Hospital
105-8471
Trial participating centre
Tokyo Jikei-kai Medical School Kashiwa Hospital
277-8567
Trial participating centre
Mitsui Memorial Hospital
101-8643
Trial participating centre
Nihon University Itabashi Hospital
173-8610
Trial participating centre
St. Marianna University School of Medicine Hospital
216-8511
Trial participating centre
Hospital Affiliating with Kanagawa Prefecture Nursing School
235-0022
Trial participating centre
Showa University Fujigaoka Hospita
227-8501
Trial participating centre
Aichi Medical University Hospital
480-1195
Trial participating centre
Chukyo Hospita
457-8510
Trial participating centre
Clinic affiliating with Inoue Hospital
564-0053
Trial participating centre
Kinki University School of Medicine Hospital
589-8511
Trial participating centre
Osaka Koseinenkin Hospital
553-0003
Trial participating centre
Hiroshima University Hospital
734-8551
Trial participating centre
Tokushima Red Cross Hospital
773-8502
Trial participating centre
Saiseikai Yahata General Hospital
805-0050
Trial participating centre
Shizuoka Genaral Hospital
420-8527
Trial participating centre
Shirasagi Clinic
546-0002
Trial participating centre
Osaka City University School of Medicine Hospital
545-8586
Trial participating centre
Teine Keijinkai Hospital
006-8555
Trial participating centre
Tokai University School of Medicine Hospital
259-1193
Trial participating centre
Tokuyama Central Hospital
745-8522
Trial participating centre
Hakodate Goryoukaku Hospital
040-8611
Trial participating centre
Kawasaki Medical School Hospital
701-0192
Trial participating centre
Saiseikai Central Hospital
108-0073
Trial participating centre
Tokyo Kyosai Hospital
153-8934
Trial participating centre
Kumamoto Central Hospital
862-0965
Sponsor information
Organisation
Baxter Limited
Sponsor details
Toranomon Hills Mori Tower 20F
1-23-1
Toranomon
Minato-ku
Tokyo
105-6320
Japan
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Baxter Limited
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in Clinical and Experimental Nephrology.
Intention to publish date
31/07/2016
Participant level data
Not expected to be available
Basic results (scientific)
Publication list