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 BLR350, 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 BLR350 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 BLR350 is used as the dialysate fluid. For group two, each time the CAPD procedure is done, 2L of Dianeal PD-2 (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?
November 2002 to April 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
BLR350-01
Study information
Scientific title
A randomized parallel-group comparative study to verify efficacy (non-inferiority) of BLR350 using Dianeal PD-2 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 BLR350 using Dianeal PD-2 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 BLR350 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-2 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. BLR350
2. Dianeal PD-2
Primary outcome measures
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
06/11/2002
Overall trial end date
15/04/2004
Reason abandoned
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-2 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 over20 years at the time of giving consent
5. Either male or female patients may be enrolled, and either inpatients or outpatients may be enrolled
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
53 patients in Arm 1 and 58 patients in arm 2 were 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. In addition, patients that have been judged to be ineligible to participate in this study by the investigator/sub-investigator
Recruitment start date
06/11/2002
Recruitment end date
26/12/2003
Locations
Countries of recruitment
Japan
Trial participating centre
Obihiro-Kosei General Hospital
080-0016
Trial participating centre
Caress Alliance Nikko-Kinen Hospital
051-8501
Trial participating centre
Yamagata University School of Medical Hospital
990-9585
Trial participating centre
Toride Kyodo General Hospital
302-0022
Trial participating centre
Kameda Medical Center
296-8602
Trial participating centre
Saitama Medical University Hospital
350-0495
Trial participating centre
Saitama Medical University Medical Center
350-8550
Trial participating centre
Tokyo Medical University Hospital
160-0023
Trial participating centre
Tokyo Jikeikai University Hospital
105-8471
Trial participating centre
Tokyo Women’s Medical University Hospital
162-8666
Trial participating centre
Juntendo University School of Medical Hospital
113-8431
Trial participating centre
Tokyo Women’s Medical University Second Hospital
116-8567
Trial participating centre
Toranomon Hospital
105-8470
Trial participating centre
Yokosuka Kyosai Hospital
238-8558
Trial participating centre
Shonan Kamakura General Hospital
247-8533
Trial participating centre
Fujita Health University Hospital
470-1192
Trial participating centre
Nara Medical University Hospital
634-8522
Trial participating centre
Okayama Saiseikai General Hospital
700-8511
Trial participating centre
Kurashiki Central Hospital
710-8602
Trial participating centre
Akane-kai Tschiya General Hospital
730-8655
Trial participating centre
Takamatsu Red Cross Hospital
760-0017
Trial participating centre
Kumamoto Central Hospital
862-0965
Trial participating centre
Saiseikai Kumamoto Hospital
861-4193
Trial participating centre
Toranomon Hospital Annex
213-8587
Trial participating centre
Nankai Hospital
876-0857
Trial participating centre
St. Luke’s International Hospital
104-8560
Trial participating centre
Tokyo Saiseikai Central Hospital
108-0073
Trial participating centre
Gifu Prefectural General Medical Center
500-8717
Trial participating centre
Hiroshima University Hospital
734-8551
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
Not defined
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
Results - basic reporting
Publication summary