Renal Failure Chronic Requiring DialysisPhase 4BOLDNCT07351357
Bisacodyl Oral for Lowering Dysfunction (of Tenckhoff Catheter)
A Phase 4 study testing Bisacodyl 5 mg in people with Renal Failure Chronic Requiring Dialysis and Peritoneal Dialysis, run by Chinese University of Hong Kong at 6 sites in Hong Kong.
Trial summary
Doctors need to insert catheter for patients who are going to have peritoneal dialysis. These peritoneal catheters can be obstructed or blocked afterward. The chance of not having smooth flow can be up to 12 and 31%. So far, constipation is one of the proposed reasons. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Failure Chronic Requiring Dialysis, Peritoneal Dialysis
- What is being tested?
- Bisacodyl 5 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 398 participants
- Where
- 6 sitesHong Kong
- Study dates
- 12 Jan 2026to 30 Sep 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18 or older and need of peritoneal dialysis
- willingness to give written consent and comply with the study protocol
Who cannot join
- known contraindication to peritoneal dialysis
- ongoing diarrhoea or active inflammatory bowel disease
- participation in another interventional study within last 30 days of randomization
- history of a psychological illness or condition that would interfere with the patient's ability to understand the requirement of the study and/or comply with the dialysis procedures
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Hong Kong6 sites, 6 recruiting
- Not yet recruiting
Princess Margaret Hospital
Kwai Chung, Kowloon, SAR
Tung Sen Shum, MBChB, 852-95774826, sts8791@ha.org.hk
- Not yet recruiting
Caritas Medical Centre
Sham Shui Po, Kowloon, SAR
Sze Kit Yuen, MBChB, 852-51365610, yuensk@ha.org.hk
- Recruiting
Prince of Wales Hospital
Shatin, NT, SAR
Kai Ming Chow, MBChB, 852-55696007, chow_kai_ming@alumni.cuhk.net
- Not yet recruiting
Prince of Wales Hospital
Shatin
- Not yet recruiting
Tseung Kwan O Hospital
Tseung Kwan O, NT, SAR
Elaine Ho, MBBS, 852-96225803, htlz01@ha.org.hk
- Not yet recruiting
Queen Elizabeth Hospital
Yau Ma Tei, NT, SAR
Hoi Wong Chan, MBBS, 852-61312675, chw019@ha.org.hk
About this study
Official title: Multi-Centre Pragmatic Randomized Controlled Trial of Bowel Preparation Before Peritoneal Dialysis Catheter Insertion
Doctors need to insert catheter for patients who are going to have peritoneal dialysis. These peritoneal catheters can be obstructed or blocked afterward. The chance of not having smooth flow can be up to 12 and 31%. So far, constipation is one of the proposed reasons. Therefore, the study is aimed to investigate whether the preventive use of laxative before the surgery can help better improve the function of the catheter and hence better flow.
Read the detailed description
This study compares the result of laxative bowel preparation versus usual care before the insertion of Tenckhoff catheters for peritoneal dialysis patients. The investigators design an open-label multi-centre randomized controlled study to evaluate the prophylactic use of laxative to reduce incidence of catheter flow dysfunction after peritoneal dialysis catheter insertion. The primary objective is to assess whether laxative prophylaxis can reduce the risk of catheter dysfunction that requires intervention. The investigators estimate that the study would need to enroll 199 peritoneal dialysis patients in each group for the study to have 80% power to detect a difference between 10% and 20% in the primary endpoint of catheter dysfunction requiring simple intervention.
- Being tested
- Bisacodyl 5 mg
- Keywords
- peritoneal dialysis, Tenckhoff catheter, laxative, bowel preparation, catheter dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bisacodyl 5 mgDrug
In the intervention arm, the protocol of prophylactic laxative is administration of oral enteric coated bisacodyl 5 mg at bedtime for two consecutive days prior to Tenckhoff catheter insertion. In the control arm, patients will receive usual care, and are allowed to continue their usual laxative, without extra prescription.
| Study group | Role | What they receive |
|---|---|---|
| Bowel preparation | Active comparator | oral bisacodyl Receives: Drug: Bisacodyl 5 mg |
| Usual care | No intervention | usual care for catheter insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Catheter dysfunction
Primary outcome is the incidence of catheter dysfunction that requires simple and invasive manipulation by fluoroscopic or surgical procedure. Catheter dysfunction refers to drainage failure, as defined by the inability to drain peritoneal dialysate effluent reliably within 45 minutes. Simple intervention includes use of irrigation of catheter with saline, fibrinolytic agent such as urokinase and extra laxative use. Invasive manipulation of catheter includes repositioning or reinsertion, either by fluoroscopic method, open surgical or laparoscopic method.
Measured: within 4 weeks of catheter insertion
Secondary outcomes (3)
Catheter dysfunction and survival
The time to catheter dysfunction requiring invasive intervention
Measured: 3 months after catheter insertion for early peritonitis
The incidence of early peritonitis (within 3 months of catheter insertion)
Peritonitis
Measured: 3 months after catheter insertion
The peritoneal catheter survival
catheter survival
Measured: 3 months after catheter insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start12 Jan 2026
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Failure Chronic Requiring DialysisStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 398 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chow Kai Ming, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07351357
- Sponsor's protocol ID
- CREC-2025-492
- Acronym
- BOLD
- Status last verified
- Oct 2026
- First submitted
- 1 Jan 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Confidentiality