Chronic Kidney Disease(CKD)Phase 3THINKNCT05732727
Intensification of Blood Pressure Lowering Therapeutics Based on Diuretics Versus Usual Management for Uncontrolled Hypertension IN Patients With Moderate to Severe Chronic Kidney Disease
A Phase 3 study testing Antihypertensive algorithm in people with Chronic Kidney Disease(CKD) and Uncontrolled Hypertension, run by University Hospital, Tours at 40 sites in France.
Trial summary
Chronic kidney disease (CKD) is a major public health issue worldwide. Hypertension is the first risk factor in patients with CKD for mortality, cardiovascular disease and end-stage renal disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease(CKD), Uncontrolled Hypertension
- What is being tested?
- Antihypertensive algorithm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 40 sitesFrance
- Study dates
- 28 Mar 2023to Mar 2029
- Phase
- Phase 3
- 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
- Male or female >=18 years with a clinical frailty score ≤5 for patient aged over 80
- Advanced or moderate chronic kidney disease (eGFR 15 to 44.9 mL/min/1.73m² using CKD-EPI formula)
- Arterial hypertension treated with at least one blood pressure lowering drug therapy among blockers of the renin-angiotensin system (ACEi or ARB), at the maximal posology tolerated by the patients stable since at least one month. Other blood pressure lowering drug therapies are tolerated in combination with or in the event of intolerance to ACE inhibitors or ARBs.
- Uncontrolled office BP
- Uncontrolled office BP (>140 and/or 90 mmHg) confirmed by home blood pressure monitoring (>135 and/or 85 mmHg) or Day-time Ambulatory Blood Pressure Monitoring
- Participant covered by or entitled to social security
- Written informed consent obtained from the participant
Who cannot join
- Patient following any measures of legal presentation
- Pregnant or breastfeeding woman
- woman of childbearing without a highly effective contraceptive measure (combined or progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device or intrauterine hormone-releasing system)
- Clinical signs of hypovolemia
- Symptomatic orthostatic hypotension
- Hyponatremia (<130 mmol/L)
Show all 16Show fewer
- Dyskalemia (<3,5 mmol/L or >5,5 mmol/L)
- Major adverse cardiovascular event during the last three months: myocardial infarction, heart failure hospitalization, stroke
- Current medical history of cancer requiring chemotherapy
- Solid organ transplantation
- Two or more diuretic agents (loop diuretic, thiazides and thiazide-like diuretics)
- Mineralocorticoid receptor antagonists
- Autosomal dominant polycystic kidney disease treated with Tolvaptan
- Contraindication to diuretics involved in the algorithm
- Severe heart failure (NYHA III_IV)
- Cirrhosis Child B-C
Trial locations and contacts
40 sites in 1 country. Contact the study team or a site near you to ask about taking part.
40 sites in 1 country
France40 sites, 37 recruiting
- Recruiting
Department of Nephrology, University Hospital of Angers
Angers, 49933
Martin PLANCHAIS, MD
Martin PLANCHAIS, MD
- Recruiting
Department of Nephrology, University Hospital of Bordeaux
Bordeaux, 33000
Pierre PFIRMANN, MD-PhD
Pierre PFIRMANN, MD-PhD
- Recruiting
AUB Santé foundation, Brest
Brest, 29200
Morgane GOSSELIN, MD
Morgane GOSSELIN, MD
- Recruiting
Department of Nephrology, University Hospital of Brest
Brest, 29200
Yannick LE MEUR, MD-PhD
Yannick LE MEUR, MD-PhD
- Recruiting
Department of Nephrology, Hospital of Chalon-sur-Saône
Chalon-sur-Saône
Magali LOUIS, MD
Magali LOUIS, MD
- Recruiting
Department of Nephrology, Hospital of Chartres
Chartres, 28630
Nestor NANKEU, MD
Nestor NANKEU, MD
- Recruiting
Department of Nephrology, University Hospital of Clermont-Ferrand
Clermont-Ferrand, 63001
Julien ANIORT, MD
Julien ANIORT, MD
- Recruiting
Department of Nephrology, Hospital of Colmar
Colmar, 68024
Alexandre KLEIN, MD
Alexandre KLEIN, MD
- Recruiting
Department of Nephrology, University Hospital of Grenoble
Grenoble, 38043
Pierre Louis CARRON, MD
Pierre Louis CARRON, MD
- Recruiting
Department of Nephrology, Hospital of Haguenau
Haguenau, 67500
Julien OTT, MD
Julien OTT, MD
- Recruiting
Department of Nephrology, Departemental Hospital of Vendée
La Roche-sur-Yon, 85925
Anne Hélène QUERARD, MD
Anne Hélène QUERARD, MD
- Recruiting
ECHO Santé Association, Le Mans
Le Mans, 72100
Louis Marie VERNIER, MD
Louis Marie VERNIER, MD
- Recruiting
Department of Nephrology, Hospital of Le Puy en Velay
Le Puy-en-Velay, 43012
Marc BOUILLER, MD
Marc BOUILLER, MD
- Recruiting
Department of Nephrology, University Hospital of Lille
Lille, 59000
Marie FRIMAT, Md-PhD
Marie FRIMAT, Md-PhD
- Recruiting
Department of Nephrology, University Hospital of Limoges
Limoges, 87042
Fatouma TOURE, MD-PhD
Fatima TOURE, MD-PhD
- Recruiting
AUB Santé foundation, Lorient
Lorient, 56100
Gabrielle DUNEAU, MD
Gabrielle DUNEAU, MD
- Recruiting
Department of Nephrology, University Hospital of Lyon
Lyon, 69003
Jean Pierre FAUVEL, MD-PhD
Jean Pierre FAUVEL, MD-PhD
- Recruiting
Department of Nephrology, University Hospital of Marseille
Marseille, 13005
Stéphane BURTEY, MD-PhD
Stéphane BURTEY, MD-PhD
- Recruiting
Department of Nephrology, Regional Hospital of Metz
Metz, 57085
Thomas QUINAUX, MD
Thomas QUINAUX, MD
- Recruiting
Department of Nephrology, Régional Hospital of Mulhouse
Mulhouse, 68100
François CHANTREL, MD
François CHANTREL, MD
- Recruiting
Department of Nephrology, University Hospital of Nantes
Nantes, 44093
Caroline GOURRAUD VERCEL, MD
Caroline GOURRAUD VERCEL, MD
- Recruiting
ECHO Santé Association, Nantes
Nantes, 44402
Lila GHOUTI TERKI, MD
Lila GHOUTI TERKI, MD
- Recruiting
Department of Nephrology, University Hospital of Nîmes
Nîmes, 30029
Olivier MORANNE, MD-PhD
Olivier MORANNE, MD-PhD
- Recruiting
Department of Nephrology, Hospital of Orléans
Orléans, 45067
Marion DEKEYSER, MD
Marion DEKEYSER, MD
- Active, not recruiting
Department of Nephrology, European Hospital Georges Pompidou, AP-HP
Paris, 75015
- Recruiting
Department of Nephrology, Necker Hospital, AP-HP
Paris, 75015
Dominique JOLY, MD-PhD
Dominique JOLY, MD-PhD
- Recruiting
Department of Nephrology, Bichat Hospital, AP-HP
Paris, 75018
François VRTOVSNIK, MD-PhD
François VRTOVSNIK, MD-PhD
- Active, not recruiting
Department of Nephrology, Tenon Hospital, AP-HP
Paris, 75020
- Recruiting
Department of Nephrology, Hospital of Perpignan
Perpignan, 66046
Sébastien CANET, MD
Sébastien CANET, MD
- Recruiting
Department of Nephrology, University Hospital of Reims
Reims, 51092
Pierre Guillaume DELIEGE, MD
Pierre Guillaume DELIEGE, MD
- Recruiting
Department of Nephrology, University Hospital of Rennes
Rennes, 35033
Thierry FROUGET, MD
Thierry FROUGET, MD
- Recruiting
Department of Nephrology, Hospital of Roubaix
Roubaix, 59100
Thomas GUINCESTRE, MD
Thomas GUINCESTRE, MD
- Recruiting
Department of Nephrology, University Hospital of Rouen
Rouen, 76230
Dominique GUERROT, MD-PHD
Dominique GUERROT, MD-PhD
- Recruiting
Department of Nephrology, University Hospital of Saint Etienne
Saint-Etienne, 42270
Christophe MARIAT, MD-PhD
Christophe MARIAT, MD-PhD
- Active, not recruiting
ECHO Santé Association, Saint Herblain
Saint-Herblain, 44819
- Recruiting
Department of Nephrology, Hospital of Saint Malo
St-Malo, 35400
Eric RENAUDINEAU, MD
Eric RENAUDINEAU, MD
- Recruiting
Department of Nephrology, Hospital of Strasbourg
Strasbourg, 67000
Nans FLORENS, MD-PhD
Nans FLORENS, MD-PhD
- Recruiting
Department of Nephrology, University Hospital of Tours
Tours, 37044
Bénédicte SAUTENET, MD
Bénédicte SAUTENET, MD
- Recruiting
Department of Nephrology, Hospital of Valenciennes
Valenciennes, 59322
Marc ULRICH, MD
Marc ULRICH, MD
- Recruiting
Department of Nephrology, University Hospital of Nancy
Vandœuvre-lès-Nancy, 54511
Adrien FLAHAULT, MD-PhD
Adrien v, MD-PhD
About this study
Official title: Intensification of Blood Pressure Lowering Therapeutics Based on Diuretics Versus Usual Management for Uncontrolled Hypertension IN Patients With Moderate to Severe Chronic Kidney Disease: an Open Label, a Cluster Randomized Controlled, Phase 3 Trial
Chronic kidney disease (CKD) is a major public health issue worldwide. Hypertension is the first risk factor in patients with CKD for mortality, cardiovascular disease and end-stage renal disease. It's now well established that lowering blood pressure (BP) reduces renal and cardiovascular complications in this high-risk population. In the general population, in addition to lifestyle interventions, the strategy to initiate and escalate a BP-lowering drug treatment is well described. The drug therapies recommended to achieve optimal BP control in the general population are the following: blockers of the renin-angiotensin system (angiotensin-converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB)), diuretics (thiazides and thiazide-like diuretics), and calcium channel blockers. For patients with CKD, the guidelines advise to start the BP-lowering agent with ACEi or ARB, but then, there is no strong evidence to support the preferential use of any particular agent in controlling BP and the results of clinical trials are discordant. In the NephroTest cohort, a French cohort of patients with CKD stage 1 to 5, among 2015 patients, 1782 had hypertension, only 54% had a diuretic and 44% had uncontrolled hypertension. In this cohort, extracellular fluid (ECF) overload was an independent determinant of hypertension, uncontrolled hypertension and apparent treatment resistant hypertension. In the same cohort, ECF overload was independently associated with end-stage kidney disease and death. Our hypothesis is that patients with CKD and uncontrolled hypertension are fluid overloaded and that the second line of treatment after an ACEi or an ARB should be a diuretic. We hypothesize that a specific algorithm to lower BP in patients with moderate to severe CKD based on diuretics will be more effective in term of cardiovascular event, mortality and evolution to end-stage kidney disease as compared to standard of care.
- Being tested
- Antihypertensive algorithm, Standard of care
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antihypertensive algorithmDrug
Antihypertensive algorithm based on diuretics agents
Standard of careDrug
standard of care management for antihypertensive therapy intensification
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Antihypertensive algorithm based on diuretics agents : the clinicians will adjust the drug therapy according to the antihypertensive algorithm based on diuretics agents. Receives: Drug: Antihypertensive algorithm |
| Control group | Active comparator | Standard of care : the clinicians will adapt the antihypertensive strategy according to his own standard of care which can be pharmacological or non-pharmacological therapies. Receives: Drug: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
End stage kidney disease
The primary endpoint is a time to event outcome, considering the following composite endpoint:
- End stage kidney disease
- eGFR decline of at least 40%
- Cardiovascular events among myocardial infarction, heart failure, hospitalization and stroke
- All cause mortality
Measured: Up to 36 months
eGFR decline of at least 40%
The primary endpoint is a time to event outcome, considering the following composite endpoint:
- End stage kidney disease
- eGFR decline of at least 40%
- Cardiovascular events among myocardial infarction, heart failure, hospitalization and stroke
- All cause mortality
Measured: Up to 36 months
Cardiovascular events
The primary endpoint is a time to event outcome, considering the following composite endpoint:
- End stage kidney disease
- eGFR decline of at least 40%
- Cardiovascular events among myocardial infarction, heart failure, hospitalization and stroke
- All cause mortality
Measured: Up to 36 months
All cause mortality
The primary endpoint is a time to event outcome, considering the following composite endpoint:
- End stage kidney disease
- eGFR decline of at least 40%
- Cardiovascular events among myocardial infarction, heart failure, hospitalization and stroke
- All cause mortality
Measured: Up to 36 months
Secondary outcomes (10)
Time to end-stage kidney disease
All components of the composite endpoint will be assessed separately
Measured: Up to 36 months
Time to eGFR decrease of at leat 40%
All components of the composite endpoint will be assessed separately
Measured: Up to 36 months
Time to the first cardiovascular event among myocardial infarction, heart failure, hospitalization and stroke
All components of the composite endpoint will be assessed separately
Measured: Up to 36 months
All-cause mortality
All components of the composite endpoint will be assessed separately
Measured: Up to 36 months
Change from baseline in blood pressure
Systolic and diastolic blood pressure at months 3 and 6 then every 6 months (home blood pressure monitoring and office blood pressure measurement),
Measured: From baseline and up to 36 months
Proportion of patients with controlled blood pressure
Proportion of patients with controlled blood pressure at 2 years (PA< 135/85mmHg with home blood pressure monitoring)
Measured: 24 months
Change from baseline in glomerular filtration rate
Change from baseline in glomerular filtration rate estimated by CKD-EPI formula at months 3 and 6 then every 6 months
Measured: From baseline and up to 36 months
Change from baseline in proteinuria (g/d) or proteinuria /creatinuria (g/g)
Change from baseline in proteinuria (g/d) or proteinuria /creatinuria (g/g) at months 3 and 6 then every 6 months
Measured: From baseline and up to 36 months
Proportion of patients who used at least one diuretic
Measured: Up to 36 months
Change from baseline in quality of life
Change from baseline in quality of life assessed by PROMIS-29 survey each year
Measured: From baseline and up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start28 Mar 2023
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease(CKD)Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized controlled
- Masking
- None (open label)
- Enrolment
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bénédicte Sautenet, MD, Principal investigator, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05732727
- Sponsor's protocol ID
- DR210320
- Other IDs
- 2022-501494-39-00
- Acronym
- THINK
- Status last verified
- Jul 2026
- First submitted
- 8 Feb 2023
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Following publication of primary results, deidentified data will be made available from the principal investigator on any reasonable request and based on a methodologically sound proposal. Data dictionaries, study protocol, Statistical Analysis Plan and Informed Consent Form could be shared under the same conditions.
Publications
Le Vilain-Abraham F, Halimi JM, Rossignol P, Laville M, Azizi M, Stengel B, Maisons V, Rouzes A, Caille A, Sautenet B. Intensification of blood pressure lowering therapeutics based on diuretics versus usual management for uncontrolled hypertension in patients with moderate to severe chronic kidney disease (THINK): protocol for an open label, two-parallel group, cluster randomised controlled, superiority, phase 3 trial. BMJ Open. 2026 Sep 17;16(9):e122192. doi: 10.1136/bmjopen-2026-122192.
PubMed 42754276
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensification of Blood Pressure Lowering Therapeutics Based on Diuretics Versus Usual Management for Uncontrolled Hypertension IN Patients With Moderate to Severe Chronic Kidney Disease: an Open Label, a Cluster Randomized Controlled, Phase 3 Trial
- ClinicalTrials.gov ID
- NCT05732727
- Acronym / sponsor ID
- THINK / DR210320
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 28 Mar 2023 (actual)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 17 Feb 2023 (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) is a major public health issue worldwide. Hypertension is the first risk factor in patients with CKD for mortality, cardiovascular disease and end-stage renal disease. It's now well established that lowering blood pressure (BP) reduces renal and cardiovascular complications in this high-risk population. In the general population, in addition to lifestyle interventions, the strategy to initiate and escalate a BP-lowering drug treatment is well described. The drug therapies recommended to achieve optimal BP control in the general population are the following: blockers of the renin-angiotensin system (angiotensin-converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB)), diuretics (thiazides and thiazide-like diuretics), and calcium channel blockers. For patients with CKD, the guidelines advise to start the BP-lowering agent with ACEi or ARB, but then, there is no strong evidence to support the preferential use of any particular agent in controlling BP and the results of clinical trials are discordant. In the NephroTest cohort, a French cohort of patients with CKD stage 1 to 5, among 2015 patients, 1782 had hypertension, only 54% had a diuretic and 44% had uncontrolled hypertension. In this cohort, extracellular fluid (ECF) overload was an independent determinant of hypertension, uncontrolled hypertension and apparent treatment resistant hypertension. In the same cohort, ECF overload was independently associated with end-stage kidney disease and death. Our hypothesis is that patients with CKD and uncontrolled hypertension are fluid overloaded and that the second line of treatment after an ACEi or an ARB should be a diuretic. We hypothesize that a specific algorithm to lower BP in patients with moderate to severe CKD based on diuretics will be more effective in term of cardiovascular event, mortality and evolution to end-stage kidney disease as compared to standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomized controlled
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Antihypertensive algorithmAntihypertensive algorithm based on diuretics agents : the clinicians will adjust the drug therapy according to the antihypertensive algorithm based on diuretics agents. |
| Control group | Active comparator | Drug: Standard of careStandard of care : the clinicians will adapt the antihypertensive strategy according to his own standard of care which can be pharmacological or non-pharmacological therapies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female >=18 years with a clinical frailty score ≤5 for patient aged over 80
- Advanced or moderate chronic kidney disease (eGFR 15 to 44.9 mL/min/1.73m² using CKD-EPI formula)
- Arterial hypertension treated with at least one blood pressure lowering drug therapy among blockers of the renin-angiotensin system (ACEi or ARB), at the maximal posology tolerated by the patients stable since at least one month. Other blood pressure lowering drug therapies are tolerated in combination with or in the event of intolerance to ACE inhibitors or ARBs.
- Uncontrolled office BP
- Uncontrolled office BP (>140 and/or 90 mmHg) confirmed by home blood pressure monitoring (>135 and/or 85 mmHg) or Day-time Ambulatory Blood Pressure Monitoring
Key exclusion criteria (16 listed)
- Patient following any measures of legal presentation
- Pregnant or breastfeeding woman
- woman of childbearing without a highly effective contraceptive measure (combined or progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device or intrauterine hormone-releasing system)
- Clinical signs of hypovolemia
- Symptomatic orthostatic hypotension
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 |
|---|---|---|
| Antihypertensive algorithmAntihypertensive algorithm based on diuretics agents | Drug | Experimental group |
| Standard of carestandard of care management for antihypertensive therapy intensification | Drug | Control group |
Primary outcome
End stage kidney disease
Time frame: Up to 36 months
The primary endpoint is a time to event outcome, considering the following composite endpoint: * End stage kidney disease * eGFR decline of at least 40% * Cardiovascular events among myocardial infarction, heart failure, hospitalization and stroke * All cause mortality
eGFR decline of at least 40%
Time frame: Up to 36 months
The primary endpoint is a time to event outcome, considering the following composite endpoint: * End stage kidney disease * eGFR decline of at least 40% * Cardiovascular events among myocardial infarction, heart failure, hospitalization and stroke * All cause mortality
Cardiovascular events
Time frame: Up to 36 months
The primary endpoint is a time to event outcome, considering the following composite endpoint: * End stage kidney disease * eGFR decline of at least 40% * Cardiovascular events among myocardial infarction, heart failure, hospitalization and stroke * All cause mortality
All cause mortality
Time frame: Up to 36 months
The primary endpoint is a time to event outcome, considering the following composite endpoint: * End stage kidney disease * eGFR decline of at least 40% * Cardiovascular events among myocardial infarction, heart failure, hospitalization and stroke * All cause mortality
10 secondary outcomes
Time to end-stage kidney disease
Time frame: Up to 36 months
Time to eGFR decrease of at leat 40%
Time frame: Up to 36 months
Time to the first cardiovascular event among myocardial infarction, heart failure, hospitalization and stroke
Time frame: Up to 36 months
All-cause mortality
Time frame: Up to 36 months
Change from baseline in blood pressure
Time frame: From baseline and up to 36 months
Proportion of patients with controlled blood pressure
Time frame: 24 months
Change from baseline in glomerular filtration rate
Time frame: From baseline and up to 36 months
Change from baseline in proteinuria (g/d) or proteinuria /creatinuria (g/g)
Time frame: From baseline and up to 36 months
Proportion of patients who used at least one diuretic
Time frame: Up to 36 months
Change from baseline in quality of life
Time frame: From baseline and up to 36 months
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 3 Aug 2026.
- Derived from this study: PubMed 42754276Le Vilain-Abraham F, Halimi JM, Rossignol P, Laville M, Azizi M, Stengel B, Maisons V, Rouzes A, Caille A, Sautenet B. Intensification of blood pressure lowering therapeutics based on diuretics versus usual management for uncontrolled hypertension in patients with moderate to severe chronic kidney disease (THINK): protocol for an open label, two-parallel group, cluster randomised controlled, superiority, phase 3 trial. BMJ Open. 2026 Sep 17;16(9):e122192. doi: 10.1136/bmjopen-2026-122192.
- Individual participant dataSharing planned: Yes. Following publication of primary results, deidentified data will be made available from the principal investigator on any reasonable request and based on a methodologically sound proposal. Data dictionaries, study protocol, Statistical Analysis Plan and Informed Consent Form could be shared under the same conditions.
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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.
Bénédicte Sautenet, MD principal investigator
University Hospital, Tours
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Antihypertensive algorithm in people with Chronic Kidney Disease(CKD) and Uncontrolled Hypertension, run by University Hospital, Tours at 40 sites in France.
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 7 inclusion and 16 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 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Bénédicte Sautenet, MD (02.34.37.96.86 ext. +33, benedicte.sautenet@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
End stage kidney disease (time frame: Up to 36 months). The study lists 4 primary outcomes in all. 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 NCT05732727, which also lists 1 linked publication.
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 3 Aug 2026.