- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07271420
Blood Pressure Control With Thiazide Diuretics in Peritoneal Dialysis Patients
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Gordon Chan, MD, MRCP
- Phone Number: 0085235052211
- Email: cck295@ha.org.hk
Study Locations
-
-
-
Hong Kong, Hong Kong
- Recruiting
- Prince of Wales Hospital. The Chinese University of Hong Kong
-
Contact:
- CC Szeto, MD, FRCP
- Phone Number: 0085235052211
- Email: ccszeto@cuhk.edu.hk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients on chronic peritoneal dialysis, with uncontrolled hypertension (SBP >140 mmHg and/or DBP >90 mmHg)
Exclusion Criteria:
- Patients with a life expectancy of less than 3 months, planned conversion to hemodialysis, or scheduled kidney transplantation within 3 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control arm
|
|
|
Active Comparator: Thiazides treatment arm
|
Thiazides diuretics
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in systolic and diastolic blood pressure
Time Frame: 90 days
|
90 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Changes in body weight
Time Frame: 90 days
|
90 days
|
|
Changes in body composition measured by bio impedance spectroscopy
Time Frame: 90 days
|
90 days
|
|
Change in urinary fractional excretion of sodium
Time Frame: 90 days
|
90 days
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- Ali 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.
- An 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.
- Chan 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Pathologic Processes
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Chronic Disease
- Disease Attributes
- Renal Insufficiency
- Renal Insufficiency, Chronic
- Pathological Conditions, Signs and Symptoms
- Hypertension
- Kidney Failure, Chronic
- Sulfur Compounds
- Organic Chemicals
- Heterocyclic Compounds
- Heterocyclic Compounds, 2-Ring
- Heterocyclic Compounds, Fused-Ring
- Sulfonamides
- Sulfones
- Chlorothiazide
- Benzothiadiazines
- Thiazides
- Hydrochlorothiazide
Other Study ID Numbers
- CREC2019.580
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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