A new peritoneal dialysis fluid for Japan: A randomized non-inferiority clinical trial of safety and efficacy
| ISRCTN | ISRCTN48112900 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48112900 |
| Secondary identifying numbers | BLR350-01 |
- 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
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 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
Contact information
Public
Toranomon Hills Mori Tower 20F
1-23-1, Toranomon, Minato-ku
Tokyo
105-6320
Japan
Study information
| Study design | Prospective randomized parallel trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Home |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet. |
| 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) |
| Study objectives | 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(s) | Institutional Review Board, Baxter Limited (Japan), 23/07/2002 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | 1. BLR350 2. Dianeal PD-2 |
| 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 study start date | 06/11/2002 |
| Completion date | 15/04/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 53 patients in Arm 1 and 58 patients in arm 2 were enrolled. |
| Total final enrolment | 113 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 06/11/2002 |
| Date of final enrolment | 26/12/2003 |
Locations
Countries of recruitment
- Japan
Study participating centres
Japan
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Sponsor information
Industry
Toranomon Hills Mori Tower 20F
1-23-1, Toranomon, Minato-ku
Tokyo
105-6320
Japan
| Website | http://www.baxter.co.jp |
|---|---|
"ROR" |
https://ror.org/02d6ew870 |
Funders
Funder type
Not defined
No information available
Results and Publications
| Intention to publish date | 31/07/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in Clinical and Experimental Nephrology. |
| IPD sharing plan | The 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.
