HypertensionPhase 4NCT07271420
Blood Pressure Control With Thiazide Diuretics in Peritoneal Dialysis Patients
A Phase 4 study testing Hydrochlorothiazide 25mg once per day in people with Hypertension and Peritoneal Dialysis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
To evaluate the blood pressure lowering effects of thiazide diuretics in patients on peritoneal dialysis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Peritoneal Dialysis, End Stage Kidney Disease (ESRD)
- What is being tested?
- Hydrochlorothiazide 25mg once per day
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jan 2020to 30 Jun 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Patients on chronic peritoneal dialysis, with uncontrolled hypertension (SBP >140 mmHg and/or DBP >90 mmHg)
Who cannot join
- Patients with a life expectancy of less than 3 months, planned conversion to hemodialysis, or scheduled kidney transplantation within 3 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital. The Chinese University of Hong Kong
Hong Kong
CC Szeto, MD, FRCP, 0085235052211, ccszeto@cuhk.edu.hk
About this study
To evaluate the blood pressure lowering effects of thiazide diuretics in patients on peritoneal dialysis
Read the detailed description
This prospective, single-center treatment-withdrawal crossover study enrolled 10 patients on chronic peritoneal dialysis (PD) and uncontrolled hypertension (SBP >140 mmHg and/or DBP >90 mmHg).
Following written informed consent, participants entered the treatment arm, receiving oral hydrochlorothiazide once daily on top of their standard of treatment for 90 days. This was followed by a 14-day washout period, after which participants entered a 90-day control period.
- Being tested
- Hydrochlorothiazide 25mg once per day
- Keywords
- Hypertension, Thiazides diuretics, End stage kidney disease, Peritoneal dialysis
- Medical subject headings
- Hypertension, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrochlorothiazide 25mg once per dayDrug
Thiazides diuretics
| Study group | Role | What they receive |
|---|---|---|
| Thiazides treatment arm | Active comparator | Not described Receives: Drug: Hydrochlorothiazide 25mg once per day |
| Control arm | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systolic and diastolic blood pressure
Measured: 90 days
Secondary outcomes (3)
Changes in body weight
Measured: 90 days
Changes in body composition measured by bio impedance spectroscopy
Measured: 90 days
Change in urinary fractional excretion of sodium
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start1 Jan 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Following written informed consent, participants entered the treatment arm, receiving oral hydrochlorothiazide once daily on top of their standard of treatment for 90 days. This was followed by a 14-day washout period, after which participants entered a 90-day control period.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chan Chun Kau Gordon, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07271420
- Sponsor's protocol ID
- CREC2019.580
- Status last verified
- Nov 2025
- First submitted
- 26 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Additional consent will need to be obtained from the participants
Publications
Agarwal R, Sinha AD, Cramer AE, Balmes-Fenwick M, Dickinson JH, Ouyang F, Tu W. Chlorthalidone for Hypertension in Advanced Chronic Kidney Disease. N Engl J Med. 2021 Dec 30;385(27):2507-2519. doi: 10.1056/NEJMoa2110730. Epub 2021 Nov 5.
PubMed 34739197Ali S, Navaneethan SD, Virani SS, Gregg LP. Revisiting diuretic choice in chronic kidney disease. Curr Opin Nephrol Hypertens. 2022 Sep 1;31(5):406-413. doi: 10.1097/MNH.0000000000000814. Epub 2022 Jul 11.
PubMed 35894274An J, Kurella Tamura M, Odden MC, Ni L, Thomas IC, Montez-Rath ME, Sim JJ. Prevalence of Apparent Treatment-Resistant Hypertension in Chronic Kidney Disease in Two Large US Health Care Systems. Clin J Am Soc Nephrol. 2022 Oct;17(10):1457-1466. doi: 10.2215/CJN.04110422. Epub 2022 Sep 9.
PubMed 36400564Chan GC, Ng JK, Chow KM, Cheng PM, Law MC, Leung CB, Li PK, Szeto CC. Polypharmacy Predicts Onset and Transition of Frailty, Malnutrition, and Adverse Outcomes in Peritoneal Dialysis Patient. J Nutr Health Aging. 2022;26(12):1054-1060. doi: 10.1007/s12603-022-1859-8.
PubMed 36519768
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Pressure Control With Thiazide Diuretics in Peritoneal Dialysis Patients
- ClinicalTrials.gov ID
- NCT07271420
- Acronym / sponsor ID
- CREC2019.580
- Keywords
- Hypertension, Thiazides diuretics, End stage kidney disease, Peritoneal dialysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the blood pressure lowering effects of thiazide diuretics in patients on peritoneal dialysis
Detailed description
This prospective, single-center treatment-withdrawal crossover study enrolled 10 patients on chronic peritoneal dialysis (PD) and uncontrolled hypertension (SBP >140 mmHg and/or DBP >90 mmHg).
Following written informed consent, participants entered the treatment arm, receiving oral hydrochlorothiazide once daily on top of their standard of treatment for 90 days. This was followed by a 14-day washout period, after which participants entered a 90-day control period.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Following written informed consent, participants entered the treatment arm, receiving oral hydrochlorothiazide once daily on top of their standard of treatment for 90 days. This was followed by a 14-day washout period, after which participants entered a 90-day control period.
| Arm | Type | Receives |
|---|---|---|
| Thiazides treatment arm | Active comparator | Drug: Hydrochlorothiazide 25mg once per day |
| Control arm | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients on chronic peritoneal dialysis, with uncontrolled hypertension (SBP >140 mmHg and/or DBP >90 mmHg)
Key exclusion criteria (1 listed)
- Patients with a life expectancy of less than 3 months, planned conversion to hemodialysis, or scheduled kidney transplantation within 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrochlorothiazide 25mg once per dayThiazides diuretics | Drug | Thiazides treatment arm |
Primary outcome
Change in systolic and diastolic blood pressure
Time frame: 90 days
3 secondary outcomes
Changes in body weight
Time frame: 90 days
Changes in body composition measured by bio impedance spectroscopy
Time frame: 90 days
Change in urinary fractional excretion of sodium
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Background: PubMed 34739197Agarwal R, Sinha AD, Cramer AE, Balmes-Fenwick M, Dickinson JH, Ouyang F, Tu W. Chlorthalidone for Hypertension in Advanced Chronic Kidney Disease. N Engl J Med. 2021 Dec 30;385(27):2507-2519. doi: 10.1056/NEJMoa2110730. Epub 2021 Nov 5.
- Background: PubMed 35894274Ali S, Navaneethan SD, Virani SS, Gregg LP. Revisiting diuretic choice in chronic kidney disease. Curr Opin Nephrol Hypertens. 2022 Sep 1;31(5):406-413. doi: 10.1097/MNH.0000000000000814. Epub 2022 Jul 11.
- Background: PubMed 36400564An J, Kurella Tamura M, Odden MC, Ni L, Thomas IC, Montez-Rath ME, Sim JJ. Prevalence of Apparent Treatment-Resistant Hypertension in Chronic Kidney Disease in Two Large US Health Care Systems. Clin J Am Soc Nephrol. 2022 Oct;17(10):1457-1466. doi: 10.2215/CJN.04110422. Epub 2022 Sep 9.
- Background: PubMed 36519768Chan GC, Ng JK, Chow KM, Cheng PM, Law MC, Leung CB, Li PK, Szeto CC. Polypharmacy Predicts Onset and Transition of Frailty, Malnutrition, and Adverse Outcomes in Peritoneal Dialysis Patient. J Nutr Health Aging. 2022;26(12):1054-1060. doi: 10.1007/s12603-022-1859-8.
- Individual participant dataSharing planned: No. Additional consent will need to be obtained from the participants
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydrochlorothiazide 25mg once per day in people with Hypertension and Peritoneal Dialysis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gordon Chan, MD, MRCP (0085235052211, cck295@ha.org.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in systolic and diastolic blood pressure (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07271420, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.