AlbuminuriaPhase 2TIMOTHYNCT05268926
TreatIng Microalbuminuria Over 24 Weeks in Subjects With or Without Type 2 Diabetes or HYpertension
A Phase 2 study testing Dapagliflozin 10Mg Tab in people with Albuminuria, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Rationale: Increased albuminuria has a relatively high prevalence in the general population (5-9%) People with increased albuminuria are more likely to develop progressive kidney and cardiovascular disease compared to persons with no albuminuria. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Albuminuria
- What is being tested?
- Dapagliflozin 10Mg Tab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteNetherlands
- Study dates
- 3 Feb 2022to 2 Feb 2023
- Phase
- Phase 2
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 45 to 80 years
- Persistent urinary albumin:creatinine ratio (UACR) ≥ 2.5 mg/mmol (~25 mg/g)
- Willing to sign informed consent
Who cannot join
- Diagnosis of type 1 diabetes mellitus
- eGFR < 25 ml/min/1.73m2
- UACR > 3500 mg/g
- Concurrent treatment with SGLT2 inhibitor
- Receiving immunosuppressive therapy within 6 months prior to enrolment
- History of diabetic ketoacidosis
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- Active malignancy aside from treated squamous cell or basal cell carcinoma of the skin.
- Initiation or changes in the dose of interventions in the renin-angiotensinaldosterone- system, diuretics, GLP-1 receptor agonists within 6 weeks of screening will not be allowed.
- Any medication, surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of medications including, but not limited to any of the following:
- History of active inflammatory bowel disease within the last six months;
- Major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection;
- Gastro-intestinal ulcers and/or gastrointestinal or rectal bleeding within last six months;
- Pancreatic injury or pancreatitis within the last six months;
- Evidence of hepatic disease as determined by any one of the following: ALT or AST values exceeding 3x ULN at the screening visit, a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt;
- Evidence of urinary obstruction or difficulty in voiding at screening
- History of severe hypersensitivity or contraindications to dapagliflozin
- Subjects who, in the assessment of the investigator, may be at risk for dehydration or volume depletion that may affect the interpretation of efficacy or safety data
- Participation in any clinical intervention study within 3 months prior to initial dosing.
- History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during the screening.
- History of noncompliance to medical regimens or unwillingness to comply with the study protocol.
- Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study.
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Rationale:
Increased albuminuria has a relatively high prevalence in the general population (5-9%) People with increased albuminuria are more likely to develop progressive kidney and cardiovascular disease compared to persons with no albuminuria. ACE-inhibitors or Angiotensin Receptor Blockers are recommended by clinical practice guidelines to lower albuminuria in patients with hypertension and diabetes. However, despite these drugs decrease albuminuria by approximately 30%, elevated albuminuria remains present in the substantial proportion of persons in the general population.
Read more
SGLT2 inhibitors are a relatively new class of drugs. Originally they were developed as oral antihyperglycemic drugs. SGLT2 inhibitors have been demonstrated to lower albuminuria and protect the kidney in patients with established chronic kidney disease (CKD) with or without diabetes. Whether the efficacy of SGTL2 inhibitors to lower albuminuria (and possibly confer kidney protection) to persons in the general population (with or without diabetes or hypertension) with persistent albuminuria who generally are at early stages of CKD is unknown.
Objective:
To assess the albuminuria lowering effects of dapagliflozin in subjects with and without diabetes or hypertension and persistent elevated albuminuria.
Study design:
Randomized placebo-controlled double blind clinical trial of 24 weeks in duration followed by a 4 weeks wash-out period
- Conditions
- Albuminuria
- Being tested
- Dapagliflozin 10Mg Tab, Placebo
- Medical subject headings
- Albuminuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10Mg TabDrug
dapagliflozin 10 mg/d or matched placebo
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Dapagliflozin 10mg/day | Active comparator | Not described Receives: Drug: Dapagliflozin 10Mg Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
urinary albumin/creatinine ratio
Change in albuminuria defined as urinary albumin/creatinine ratio: UACR) with dapagliflozin 10mg/d for 24 weeks relative to placebo
Measured: 24 weeks
Secondary outcomes (6)
systolic and diastolic blood pressure
Change in systolic and diastolic blood pressure: effect of dapagliflozin 10mg/d compared to placebo on change in systolic and diastolic blood pressure
Measured: 24 weeks
body weight
change in body weight: effect of dapagliflozin 10mg/d compared to placebo on change in body
Measured: 24 weeks
HbA1c
change in HbA1c: effect of dapagliflozin 10mg/day compared to placebo on change in HbA1c
Measured: 24 weeks
eGFR
change in eGFR: effect of dapagliflozin 10mg/day compared to placebo on change in eGFR
Measured: 24 weeks
change in UACR
difference in proportion of patients with ≥30%, 40%, 50% change in UACR from baseline at week 24.: effect of dapagliflozin 10mg/day compared to placebo on the proportion of patients with ≥30%, 40%, 50% change in UACR
Measured: 24 weeks
number of SAE's and AE's
Safety of dapagliflozin vs Placebo: number of SAE's and AE's reported by the subject or investigator if qualified as: reason for discontinuation, volume depletion, fracture, diabetic ketoacidosis, amputation and adverse events leading to amputation, urinary tract infection, genital infections and hypoglycemia
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start3 Feb 2022
- Primary completion2 Feb 2023
- Study completion2 Feb 2023
Why it stopped: Due to a delayed start-up and delayed patient inclusion in combination with new available scientific data, continuation of the clinical study no longer serves a scientific purpose.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlbuminuriaStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05268926
- Sponsor's protocol ID
- 2021/1001
- Other IDs
- 2021-004073-31
- Acronym
- TIMOTHY
- Status last verified
- Apr 2024
- First submitted
- 2 Dec 2021
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TreatIng Microalbuminuria Over 24 Weeks in Subjects With or Without Type 2 Diabetes or HYpertension
- ClinicalTrials.gov ID
- NCT05268926
- Acronym / sponsor ID
- TIMOTHY / 2021/1001
- Conditions
- Albuminuria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to a delayed start-up and delayed patient inclusion in combination with new available scientific data, continuation of the clinical study no longer serves a scientific purpose.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 3 Feb 2022 (actual)
- Primary completion
- 2 Feb 2023 (actual)
- Study completion
- 2 Feb 2023 (actual)
- First posted
- 7 Mar 2022 (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.
Rationale:
Increased albuminuria has a relatively high prevalence in the general population (5-9%) People with increased albuminuria are more likely to develop progressive kidney and cardiovascular disease compared to persons with no albuminuria. ACE-inhibitors or Angiotensin Receptor Blockers are recommended by clinical practice guidelines to lower albuminuria in patients with hypertension and diabetes. However, despite these drugs decrease albuminuria by approximately 30%, elevated albuminuria remains present in the substantial proportion of persons in the general population.
SGLT2 inhibitors are a relatively new class of drugs. Originally they were developed as oral antihyperglycemic drugs. SGLT2 inhibitors have been demonstrated to lower albuminuria and protect the kidney in patients with established chronic kidney disease (CKD) with or without diabetes. Whether the efficacy of SGTL2 inhibitors to lower albuminuria (and possibly confer kidney protection) to persons in the general population (with or without diabetes or hypertension) with persistent albuminuria who generally are at early stages of CKD is unknown.
Objective:
To assess the albuminuria lowering effects of dapagliflozin in subjects with and without diabetes or hypertension and persistent elevated albuminuria.
Study design:
Randomized placebo-controlled double blind clinical trial of 24 weeks in duration followed by a 4 weeks wash-out period
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Dapagliflozin 10mg/day | Active comparator | Drug: Dapagliflozin 10Mg Tab |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 45 to 80 years
- Persistent urinary albumin:creatinine ratio (UACR) ≥ 2.5 mg/mmol (~25 mg/g)
- Willing to sign informed consent
Key exclusion criteria (22 listed)
- Diagnosis of type 1 diabetes mellitus
- eGFR < 25 ml/min/1.73m2
- UACR > 3500 mg/g
- Concurrent treatment with SGLT2 inhibitor
- Receiving immunosuppressive therapy within 6 months prior to enrolment
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 |
|---|---|---|
| Dapagliflozin 10Mg Tabdapagliflozin 10 mg/d or matched placebo | Drug | Dapagliflozin 10mg/day |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
urinary albumin/creatinine ratio
Time frame: 24 weeks
Change in albuminuria defined as urinary albumin/creatinine ratio: UACR) with dapagliflozin 10mg/d for 24 weeks relative to placebo
6 secondary outcomes
systolic and diastolic blood pressure
Time frame: 24 weeks
body weight
Time frame: 24 weeks
HbA1c
Time frame: 24 weeks
eGFR
Time frame: 24 weeks
change in UACR
Time frame: 24 weeks
number of SAE's and AE's
Time frame: 24 weeks
Results and safety
The study was stopped early (reason given: Due to a delayed start-up and delayed patient inclusion in combination with new available scientific data, continuation of the clinical study no longer serves a scientific purpose.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dapagliflozin 10Mg Tab in people with Albuminuria, run by University Medical Center Groningen at 1 site in Netherlands.
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 22 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: stopped early, as of the sponsor's last update on 17 Apr 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 Netherlands. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Due to a delayed start-up and delayed patient inclusion in combination with new available scientific data, continuation of the clinical study no longer serves a scientific purpose.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
urinary albumin/creatinine ratio (time frame: 24 weeks). 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 17 Apr 2024.