Condition category
Urological and Genital Diseases
Date applied
02/02/2016
Date assigned
08/03/2016
Last edited
08/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Public

Primary contact

Mr Shoji Saraya

ORCID ID

Contact details

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

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

http://www.baxter.co.jp

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

Publication citations

Additional files

Editorial Notes