ProteinuriaNCT06491940
Comparison of the Role of Losartan Alone vs Hydrochlorothiazide Plus Losartan
A study testing Losartan and Losartan + Hydrochlorothiazide in people with Proteinuria, run by RESnTEC, Institute of Research at 1 site in Pakistan.
Trial summary
Losartan, an angiotensin II receptor blocker, has already been established as a treatment for diabetic nephropathy due to its ability to reduce blood pressure and mitigate the progression of kidney damage. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Proteinuria
- What is being tested?
- Losartan and Losartan + Hydrochlorothiazide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2024to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both genders with ≥18 years of age.
- Presence of proteinuria/albuminuria at time of screening.
- Creatinine clearance of 30 mL/min or higher.
Who cannot join
- A systolic blood pressure of 180 mm Hg or higher, a diastolic blood pressure of 110 mm Hg or higher.
- Presence of a second primary renal disease in addition to diabetic nephropathy.
- Patients with type 1 diabetes.
- A history of a cardiovascular or cerebrovascular event within 3 months before inclusion.
- Serum potassium of 6.0 mmol/L or higher.
- Transplantation or immunosuppressive treatment.
- Contraindication for the use of losartan or hydrochlorothiazide.
- Pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Medical department, Bahawal Victoria Hospital
Bahawalpur, Punjab Province, 06318
About this study
Official title: Comparison of the Role of Losartan Alone vs Hydrochlorothiazide Plus Losartan on Proteinuria in Diabetic Nephropathy Patients
Losartan, an angiotensin II receptor blocker, has already been established as a treatment for diabetic nephropathy due to its ability to reduce blood pressure and mitigate the progression of kidney damage. However, the addition of a diuretic like hydrochlorothiazide may offer synergistic benefits in reducing proteinuria by addressing both the underlying renal pathology and potential volume overload in these patients. The current study aims at determining and comparing the role of losartan alone vs hydrochlorothiazide plus losartan in reducing proteinuria in diabetic nephropathy patients.
- Conditions
- Proteinuria
- Being tested
- Losartan, Losartan + Hydrochlorothiazide
- Medical subject headings
- Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LosartanDrug
Patients will receives Losartan (LS) 50 mg per day.
Losartan + HydrochlorothiazideDrug
Patients will be given Losartan LS (50 mg per day) and Hydrochlorothiazide (HCTZ) 12.5 mg per day as a combination therapy.
| Study group | Role | What they receive |
|---|---|---|
| Losartan group | Experimental | Patients will receive Losartan (LS) 50 mg per day. Receives: Drug: Losartan |
| Losartan + Hydrochlorothiazide | Experimental | Patients will be given losartan LS (50 mg per day) and Hydrochlorothiazide (HCTZ) 12.5 mg per day as a combination therapy. Receives: Drug: Losartan + Hydrochlorothiazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of proteinuria
Efficacy will be labeled yes if reduction of proteinuria/albuminuria from the value before commencing treatment will be observed.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start1 Aug 2024 (estimated)
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProteinuriaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RESnTEC, Institute of Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06491940
- Sponsor's protocol ID
- LosartanBVH
- Status last verified
- Jul 2024
- First submitted
- 1 Jul 2024
- Last updated
- 9 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be shared with other researchers on a reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Role of Losartan Alone vs Hydrochlorothiazide Plus Losartan on Proteinuria in Diabetic Nephropathy Patients
- ClinicalTrials.gov ID
- NCT06491940
- Acronym / sponsor ID
- LosartanBVH
- Conditions
- Proteinuria
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- RESnTEC, Institute of ResearchUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 9 Jul 2024 (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.
Losartan, an angiotensin II receptor blocker, has already been established as a treatment for diabetic nephropathy due to its ability to reduce blood pressure and mitigate the progression of kidney damage. However, the addition of a diuretic like hydrochlorothiazide may offer synergistic benefits in reducing proteinuria by addressing both the underlying renal pathology and potential volume overload in these patients. The current study aims at determining and comparing the role of losartan alone vs hydrochlorothiazide plus losartan in reducing proteinuria in diabetic nephropathy patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Losartan group | Experimental | Drug: LosartanPatients will receive Losartan (LS) 50 mg per day. |
| Losartan + Hydrochlorothiazide | Experimental | Drug: Losartan + HydrochlorothiazidePatients will be given losartan LS (50 mg per day) and Hydrochlorothiazide (HCTZ) 12.5 mg per day as a combination therapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients of both genders with ≥18 years of age.
- Presence of proteinuria/albuminuria at time of screening.
- Creatinine clearance of 30 mL/min or higher.
Key exclusion criteria (8 listed)
- A systolic blood pressure of 180 mm Hg or higher, a diastolic blood pressure of 110 mm Hg or higher.
- Presence of a second primary renal disease in addition to diabetic nephropathy.
- Patients with type 1 diabetes.
- A history of a cardiovascular or cerebrovascular event within 3 months before inclusion.
- Serum potassium of 6.0 mmol/L or higher.
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 |
|---|---|---|
| LosartanPatients will receives Losartan (LS) 50 mg per day. | Drug | Losartan group |
| Losartan + HydrochlorothiazidePatients will be given Losartan LS (50 mg per day) and Hydrochlorothiazide (HCTZ) 12.5 mg per day as a combination therapy. | Drug | Losartan + Hydrochlorothiazide |
Primary outcome
Reduction of proteinuria
Time frame: 4 months
Efficacy will be labeled yes if reduction of proteinuria/albuminuria from the value before commencing treatment will be observed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Individual participant dataSharing planned: No. Data will be shared with other researchers on a reasonable request.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Losartan and Losartan + Hydrochlorothiazide in people with Proteinuria, run by RESnTEC, Institute of Research at 1 site in Pakistan.
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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 9 Jul 2024. 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 Pakistan. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Wasim Zahid (03336361025, drwasimzahid@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of proteinuria (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2024.