Chronic Kidney DiseaseSTIMULUS-CKDNCT07604922
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
A study testing HEMI device and SPG-NINOX device in people with Chronic Kidney Disease and Hypertension (HTN), run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
This prospective, single-center clinical investigation conducted in France will evaluate two non-invasive investigational devices (HEMI and SPG-NINOX) designed to assess microcirculation in adults. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease, Hypertension (HTN), Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- HEMI device and SPG-NINOX device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2026to 15 Sep 2028
- Phase
- Interventional
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Common Inclusion Criteria:
- Adults aged over 18 years, of both sexes
- Patients eligible for or affiliated with a social security scheme
- Patients who have provided written informed consent to participate in the study
- Common Exclusion Criteria:
- Inability to give informed consent
Show all 22Show fewer
- Persons under legal protection (guardianship, trusteeship, or court protection)
- Language barrier or psychological refusal to read the information
- Medical conditions with a life expectancy < 1 year according to clinical judgment
- Ongoing participation restriction due to another clinical research study
- Pregnant women (due to physiological hemodynamic changes in blood pressure and arterial stiffness during pregnancy)
- Cardiac arrhythmias: current atrial fibrillation or high-degree atrioventricular block
- Stable cardiovascular treatment in the previous 1 month
- Prior diagnosis of type 2 diabetes
- Stable cardiovascular treatment in the previous 1 month
- Moderate CKD (eGFR between 30 and 60 mL/min) (CKD-EPI)
- Patients scheduled for arterial stiffness assessment as part of routine care
- Stable cardiovascular treatment in the previous 1 month
- Severe CKD (GFR < 30 mL/min for ≥ 2 months)
- Patients scheduled for arterial stiffness assessment as part of routine care
- Stable cardiovascular treatment the previous 1 month
- Exclusion: No specific exclusion criteria beyond common exclusions20 / 48 C25-07_Protocole_ V1.0_01.12.2025 Healthy Volunteers Group
Who cannot join
- Hypertension Group
- CKD with GFR <60 mL/min
- ACR > 30 mg/mmol
- Type 2 diabetes Type 2 Diabetes Group
- CKD with GFR < 60 mL/min
- ACR > 30 mg/mmol Moderate CKD Group
Show all 11Show fewer
- No specific exclusion criteria beyond common exclusions Severe CKD Group
- Moderate or severe CKD (GFR < 60 mL/min) (CKD-EPI)
- Hypertension
- Type 2 diabetes
- Stable cardiovascular treatment in the previous 1 month
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
INSERM U970, Equipe 7, 56 rue Leblanc
Paris, 75015
Rosa Maria BRUNO, Pr, +33 1 53 98 79 67, rosa-maria.bruno@inserm.fr
Rosa Maria BRUNO, Pr
About this study
This prospective, single-center clinical investigation conducted in France will evaluate two non-invasive investigational devices (HEMI and SPG-NINOX) designed to assess microcirculation in adults. The study will include 165 participants divided into five groups (33 per group): healthy volunteers, patients with hypertension without chronic kidney disease (CKD), patients with type 2 diabetes without CKD, patients with moderate CKD, and patients with severe CKD. The primary objective is to compare baseline small vessel pressure measured with the HEMI (Multi-spectral optical system for microcirculation hemodynamics) device across groups in order to identify microvascular alterations associated with cardiometabolic and renal disease. Secondary objectives include assessment of microvascular responses after post-ischemic hyperemia, evaluation of SPG-derived (Speckle plethysmography) small vessel flow and volume parameters, comparison with reference vascular measurements (including SphygmoCor and ultra-high frequency ultrasound), and evaluation of feasibility, acceptability, and measurement reproducibility. Participation is non-randomized, based on participants' pre-existing clinical condition, and study procedures are non-invasive with an expected visit duration of approximately 60 minutes.
- Being tested
- HEMI device, SPG-NINOX device
- Medical subject headings
- Renal Insufficiency, Chronic, Hypertension, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEMI deviceDevice
Non-invasive investigational device used to assess microcirculation through physiological signal acquisition and derivation of microvascular parameters, including small vessel pressure at baseline. Measurements are performed during a single study visit under standardized conditions. In predefined subgroups, additional measurements may be performed after post-ischemic hyperemia and for reproducibility assessment.
SPG-NINOX deviceDevice
Non-invasive investigational device used to assess microcirculation through physiological signal acquisition and derivation of microvascular parameters, including small vessel flow and volume-related measures. Measurements are performed during a single study visit under standardized conditions.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Experimental | Adults without known hypertension, type 2 diabetes, or chronic kidney disease, undergoing non-invasive microcirculation assessment with the investigational devices (HEMI and SPG-NINOX) during a single study visit. Receives: Device: HEMI device; Device: SPG-NINOX device |
| Hypertension Without Chronic Kidney Disease | Experimental | Adults with hypertension and without chronic kidney disease, undergoing non-invasive microcirculation assessment with the investigational devices (HEMI and SPG-NINOX) during a single study visit. Receives: Device: HEMI device; Device: SPG-NINOX device |
| Type 2 Diabetes Mellitus Without Chronic Kidney Disease | Experimental | Adults with type 2 diabetes mellitus and without chronic kidney disease, undergoing non-invasive microcirculation assessment with the investigational devices (HEMI and SPG-NINOX) during a single study visit. Receives: Device: HEMI device; Device: SPG-NINOX device |
| Moderate Chronic Kidney Disease | Experimental | Adults with moderate chronic kidney disease, undergoing non-invasive microcirculation assessment with the investigational devices (HEMI and SPG-NINOX) during a single study visit. Receives: Device: HEMI device; Device: SPG-NINOX device |
| Severe Chronic Kidney Disease | Experimental | Adults with severe chronic kidney disease, undergoing non-invasive microcirculation assessment with the investigational devices (HEMI and SPG-NINOX) during a single study visit. Receives: Device: HEMI device; Device: SPG-NINOX device |
What is being measured
The primary outcome is the main question the study is designed to answer.
HEMI-derived small vessel pressure at baseline
Small vessel pressure derived from the HEMI non-invasive investigational device under standardized resting conditions at baseline. The primary analysis compares values across the five study groups.
Measured: Baseline (single study visit, approximately 60 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start15 Sep 2026 (estimated)
- Primary completion15 Mar 2028 (estimated)
- Study completion15 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned in a non-randomized manner to one of five parallel groups according to their pre-existing clinical condition (healthy volunteers, hypertension without CKD, type 2 diabetes without CKD, moderate CKD, severe CKD). All groups undergo the same non-invasive study assessments with the investigational devices (HEMI and SPG-NINOX) during a single study visit, with comparisons performed across groups. Additional predefined subgroups may undergo supplementary assessments (e.g., post-ischemic hyperemia or reproducibility testing).
- Masking
- None (open label)
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- University of Turku, Imec
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07604922
- Sponsor's protocol ID
- C25-07
- Acronym
- STIMULUS-CKD
- Status last verified
- May 2026
- First submitted
- 18 May 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No