Chronic Kidney DiseasesDYNAMONCT06572215
DYNAMic Renal Assessment: NOvel Methods to Assess KIDNEY Functional Reserve
An observational study of Chronic Kidney Diseases, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
This is a feasibility study to assess new, more practical ways of measuring renal reserve. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Dapagliflozin
- Type of treatment
- Pill or oral medicine
- How many people
- 44 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Dec 2023to 31 Dec 2027
- Phase
- Observational
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: : 44 Participants
Who may be able to join
- Patients with sickle cell nephropathy, diagnosed clinically or histologically. Sickle Cell patients will be confirmed Hb SS and eGFR (CKD-EPI) ≥ 135 ml/min/1.73m2 OR
- Previous living kidney donation
- Age ≥ 4No contraindication or known allergy to any trial medications.
- Willing and able to provide written informed consent
Who cannot join
- Aged \< 40
- Unable or unwilling to provide informed consent
- Breastfeeding or pregnant women
- Patients involved in other interventional research studies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
King's College Hospital
London
Pearl Dulawan, 02032995658, pearldulawan@nhs.net
About this study
This is a feasibility study to assess new, more practical ways of measuring renal reserve.
Read the detailed description
Quantification of glomerular filtration rate (GFR) over time is the standard assessment of kidney function. In clinical practice, the endogenous marker, 'serum creatinine' concentration, is used as a static assessment of kidney function to estimate GFR. However, serum creatinine fails to increase until at least 50% of kidney tissue is lost,[2] thus is an inadequate indicator of early CKD.
GFR like many other physiological processes is not static and augments temporarily to stimuli such as exercise and protein intake, by up to 25% from baseline in healthy individuals.[3] Similar to cardiac function stress tests which predict adverse outcomes, inability to respond to renal stressors or 'reduced renal reserve' has been demonstrated to occur prior to development of CKD (e.g. in patients with diabetes and previous acute kidney injury (AKI)) and is associated with vulnerability to future AKI, despite the presence of apparently normal kidney function measured by serum creatinine concentration.[4] Renal reserve is lost with progressive CKD,[4] and has also been demonstrated to relate to severity of histological lesions.[5]
Current measurements of renal reserve (stimulated increase in GFR due to augmented renal blood flow above basal fasting values) involve administration of a compound that is freely filtered by the glomerulus, unaffected by tubular function and is physiologically inert, with assessment before and after an oral protein load or amino acid infusion which induces arterial vasodilation, increasing renal blood flow and GFR
The study proposes a comparison of two novel methods of 'dynamic renal function testing' with renal reserve testing.
- Conditions
- Chronic Kidney Diseases
- Being tested
- Dapagliflozin
- 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.
DapagliflozinDrug
On Day 3 to 16, participants will take 10mg dapaglifozin (SGLT-2 inhibitor) orally once daily.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Participants | Not described Receives: Drug: Dapagliflozin | |
| Patients with hyperfiltration | Not described Receives: Drug: Dapagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in eGFR from baseline to 2hours after oral protein load
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start14 Dec 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06572215
- Sponsor's protocol ID
- KCH23-128
- Acronym
- DYNAMO
- Status last verified
- Mar 2026
- First submitted
- 23 Aug 2024
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DYNAMic Renal Assessment: NOvel Methods to Assess KIDNEY Functional Reserve
- ClinicalTrials.gov ID
- NCT06572215
- Acronym / sponsor ID
- DYNAMO / KCH23-128
- Conditions
- Chronic Kidney Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- 14 Dec 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Aug 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.
This is a feasibility study to assess new, more practical ways of measuring renal reserve.
Detailed description
Quantification of glomerular filtration rate (GFR) over time is the standard assessment of kidney function. In clinical practice, the endogenous marker, 'serum creatinine' concentration, is used as a static assessment of kidney function to estimate GFR. However, serum creatinine fails to increase until at least 50% of kidney tissue is lost,[2] thus is an inadequate indicator of early CKD.
GFR like many other physiological processes is not static and augments temporarily to stimuli such as exercise and protein intake, by up to 25% from baseline in healthy individuals.[3] Similar to cardiac function stress tests which predict adverse outcomes, inability to respond to renal stressors or 'reduced renal reserve' has been demonstrated to occur prior to development of CKD (e.g. in patients with diabetes and previous acute kidney injury (AKI)) and is associated with vulnerability to future AKI, despite the presence of apparently normal kidney function measured by serum creatinine concentration.[4] Renal reserve is lost with progressive CKD,[4] and has also been demonstrated to relate to severity of histological lesions.[5]
Current measurements of renal reserve (stimulated increase in GFR due to augmented renal blood flow above basal fasting values) involve administration of a compound that is freely filtered by the glomerulus, unaffected by tubular function and is physiologically inert, with assessment before and after an oral protein load or amino acid infusion which induces arterial vasodilation, increasing renal blood flow and GFR
The study proposes a comparison of two novel methods of 'dynamic renal function testing' with renal reserve testing.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Participants | – | Drug: Dapagliflozin |
| Patients with hyperfiltration | – | Drug: Dapagliflozin |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- : 44 Participants
Key inclusion criteria (4 listed)
- Patients with sickle cell nephropathy, diagnosed clinically or histologically. Sickle Cell patients will be confirmed Hb SS and eGFR (CKD-EPI) ≥ 135 ml/min/1.73m2 OR
- Previous living kidney donation
- Age ≥ 4No contraindication or known allergy to any trial medications.
- Willing and able to provide written informed consent
Key exclusion criteria (4 listed)
- Aged \< 40
- Unable or unwilling to provide informed consent
- Breastfeeding or pregnant women
- Patients involved in other interventional research studies.
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 |
|---|---|---|
| DapagliflozinOn Day 3 to 16, participants will take 10mg dapaglifozin (SGLT-2 inhibitor) orally once daily. | Drug | Healthy Participants, Patients with hyperfiltration |
Primary outcome
Change in eGFR from baseline to 2hours after oral protein load
Time frame: 2 hours
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 1 Apr 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
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 4 inclusion and 4 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 1 Apr 2026. 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 United Kingdom. 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?
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 Kate Bramham, Doctor (0203 299 9000, kch-tr.research@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in eGFR from baseline to 2hours after oral protein load (time frame: 2 hours). 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 1 Apr 2026.