Secondary HyperparathyroidismNCT03082742
The Effect of Diuretics on Mineral and Bone Disorder in Chronic Kidney Disease Patients
A study testing Hydrochlorothiazide and Furosemide in people with Secondary Hyperparathyroidism and Chronic Kidney Disease, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Chronic kidney disease (CKD) patients often have associated systemic hypertension due to volume retention, as one of the mechanisms, therefore the use of diuretics is widespread in this population. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Secondary Hyperparathyroidism, Chronic Kidney Disease
- What is being tested?
- Hydrochlorothiazide and Furosemide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2015to Jun 2018
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Estimated Glomerular Filtration Rate (calculated by CKD-EPI) between 30 and 60 ml/min
Who cannot join
- Diabetes;
- chronic use of: steroid, bisphosphonates and calcium carbonate
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital das Clinicas
São Paulo, São Paulo, 05403-000
Rosilene M Elias, M.D, Ph.D, +5511 2661-7167, rosilenemotta@hotmail.com
Rosilene M Elias, M.D., Ph.D
About this study
Official title: The Effect of Thiazide and Loop Diuretic on Mineral and Bone Disorder in Chronic Kidney Disease Patients
Chronic kidney disease (CKD) patients often have associated systemic hypertension due to volume retention, as one of the mechanisms, therefore the use of diuretics is widespread in this population. One of the major complications of CKD is mineral and bone metabolism disorder (CKD-MBD), which include changes in the levels of calcium, phosphorus, vitamin D deficiency, increased circulating levels of fibroblast growth factor (FGF-23) and parathyroid hormone (PTH). These alterations are responsible for fractures, cardiovascular disease and mortality among patients with CKD. According to diuretic mechanism of action, sometimes increasing serum calcium (in the case of furosemide), sometimes decreasing it (in the case of thiazide), it is expected that the serum calcium may be altered, even within the range of normality, with consequent impact on the levels of PTH. Although most studies have shown that the use of thiazide diuretics decreases the risk of fractures, some showed the opposite. Similarly, although most studies have shown increased risk of fracture in association to loop diuretics use, some have failed in demonstrated this outcome. Only one study, a cohort study in a population of CKD, showed that furosemide was directly related to increased calciuria and PTH levels and the use of thiazide, in turn, showed completely opposite effect. However, certain issues are still not completely solved, for example, the interference of renal function itself on calciuria. It is possible that calciuria is not a so simple explanation that justifies the PTH levels changes, as no correlation was seen between calciuria and PTH levels. Better understanding of the exact relationship between the use of diuretics and the impact on CKD-MBD may be an alternative intervention, easily accessible and relatively inexpensive. The purpose of this study is to evaluate the impact of diuretic, specifically hydrochlorothiazide and furosemide, on bone architecture and mineral metabolism.
Read the detailed description
This is a prospective randomized study to test the effects of thiazide and furosemide in bone parameters, which will be assessed by peripheral micro-tomography at baseline and 12 months later. The role of calciuria in these possible changes will be tested.
- Being tested
- Hydrochlorothiazide, Furosemide
- Keywords
- diuretics, furosemide, hydrochlorothiazide, CKD-MBD, HRpQCT, parathyroid hormone
- Medical subject headings
- Hyperparathyroidism, Secondary, Renal Insufficiency, Chronic, Chronic Kidney Disease-Mineral and Bone Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrochlorothiazideDrug
FurosemideDrug
| Study group | Role | What they receive |
|---|---|---|
| Furosemide | Active comparator | Use of Furosemide, 40mg (1 tablet) per day, over 12 months Receives: Drug: Furosemide |
| Hydrochlorothiazide | Active comparator | Use of Hydrochlorothiazide, 25mg (1 tablet) per day, over 12 months Receives: Drug: Hydrochlorothiazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parathyroid hormone (PTH) level.
Bone metabolism
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study start1 Aug 2015
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary HyperparathyroidismStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rosilene M Elias, M.D., Ph.D, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03082742
- Sponsor's protocol ID
- Diuretics - CKD-MBD
- Status last verified
- Oct 2017
- First submitted
- 27 Feb 2017
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Thiazide and Loop Diuretic on Mineral and Bone Disorder in Chronic Kidney Disease Patients
- ClinicalTrials.gov ID
- NCT03082742
- Acronym / sponsor ID
- Diuretics - CKD-MBD
- Keywords
- diuretics, furosemide, hydrochlorothiazide, CKD-MBD, HRpQCT, parathyroid hormone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 17 Mar 2017 (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.
Chronic kidney disease (CKD) patients often have associated systemic hypertension due to volume retention, as one of the mechanisms, therefore the use of diuretics is widespread in this population. One of the major complications of CKD is mineral and bone metabolism disorder (CKD-MBD), which include changes in the levels of calcium, phosphorus, vitamin D deficiency, increased circulating levels of fibroblast growth factor (FGF-23) and parathyroid hormone (PTH). These alterations are responsible for fractures, cardiovascular disease and mortality among patients with CKD. According to diuretic mechanism of action, sometimes increasing serum calcium (in the case of furosemide), sometimes decreasing it (in the case of thiazide), it is expected that the serum calcium may be altered, even within the range of normality, with consequent impact on the levels of PTH. Although most studies have shown that the use of thiazide diuretics decreases the risk of fractures, some showed the opposite. Similarly, although most studies have shown increased risk of fracture in association to loop diuretics use, some have failed in demonstrated this outcome. Only one study, a cohort study in a population of CKD, showed that furosemide was directly related to increased calciuria and PTH levels and the use of thiazide, in turn, showed completely opposite effect. However, certain issues are still not completely solved, for example, the interference of renal function itself on calciuria. It is possible that calciuria is not a so simple explanation that justifies the PTH levels changes, as no correlation was seen between calciuria and PTH levels. Better understanding of the exact relationship between the use of diuretics and the impact on CKD-MBD may be an alternative intervention, easily accessible and relatively inexpensive. The purpose of this study is to evaluate the impact of diuretic, specifically hydrochlorothiazide and furosemide, on bone architecture and mineral metabolism.
Detailed description
This is a prospective randomized study to test the effects of thiazide and furosemide in bone parameters, which will be assessed by peripheral micro-tomography at baseline and 12 months later. The role of calciuria in these possible changes will be tested.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Furosemide | Active comparator | Drug: FurosemideUse of Furosemide, 40mg (1 tablet) per day, over 12 months |
| Hydrochlorothiazide | Active comparator | Drug: HydrochlorothiazideUse of Hydrochlorothiazide, 25mg (1 tablet) per day, over 12 months |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Estimated Glomerular Filtration Rate (calculated by CKD-EPI) between 30 and 60 ml/min
Key exclusion criteria (2 listed)
- Diabetes;
- chronic use of: steroid, bisphosphonates and calcium carbonate
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 | Drug | Hydrochlorothiazide |
| Furosemide | Drug | Furosemide |
Primary outcome
Parathyroid hormone (PTH) level.
Time frame: 12 months
Bone metabolism
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
- Individual participant dataSharing planned: No
Related trials for Secondary Hyperparathyroidism
RecruitingPhase 3
Study of MT1013 for the Treatment of Patients With Secondary Hyperparathyroidism
Secondary Hyperparathyroidism, Chronic Kidney Disease
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
Not yet recruitingPhase 3
A Study of PLS240 in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
Chronic Kidney Disease (CKD), Secondary Hyperparathyroidism
Enrolling by invitationObservational study
Strategies for Proactive Health in People With Kidney Function Decline
Renal Insufficiency,Chronic, Dietary Intake Patterns
Not yet recruitingObservational study
Osteoporosis & Renal Disease: Research in Primary Health Care Services
Osteoporosis, Chronic Kidney Disease Mineral and Bone Disorder
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.
Rosilene M Elias, M.D., Ph.D principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrochlorothiazide and Furosemide in people with Secondary Hyperparathyroidism and Chronic Kidney Disease, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 2 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 26 Oct 2017. 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 Brazil. 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 Rosilene M Elias, M.D., Ph.D (+5511 26617167, rosilenemotta@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parathyroid hormone (PTH) level. (time frame: 12 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 26 Oct 2017.