Chronic Kidney DiseasesPhase 2DIAMONDNCT03190694
Effects of Dapagliflozin in Non-diabetic Patients With Proteinuria
A Phase 2 study testing Dapagliflozin 10mg in people with Chronic Kidney Diseases and Proteinuria, run by Hiddo Lambers Heerspink at 7 sites in 3 countries.
Trial summary
This study tests the hypothesis that dapagliflozin lowers proteinuria in patients with non-diabetic chronic kidney disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Kidney Diseases, Proteinuria
- What is being tested?
- Dapagliflozin 10mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 12 Nov 2017to 1 Dec 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 and ≤75 years
- Urinary protein excretion > 500 mg/g and ≤ 3500 mg/g in a 24-hr urine collection eGFR ≥ 25 mL/min/1.73m2
- On a stable dose of an ACEi or ARB for at least 4 weeks prior to randomization
- Willing to sign informed consent
- Women of Child-Bearing Potential (WOCBP):
- WOCBP must be using an acceptable method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the last dose of study drug in such a manner that the risk of pregnancy is minimized.
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- WOCBP must have a negative serum or urine pregnancy test result (minimum sensitivity 25 IU/L or equivalent units of HCG) within 0 to 72 hours before the first dose of study drug.
- Women must not be breast-feeding.
- WOCBP comprises women who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or who are not post-menopausal.
Who cannot join
- Diagnosis of type 1 or type 2 diabetes mellitus
- Urinary protein excretion > 3500 mg/day
- Peripheral Vascular Disease
- Autosomal dominant polycystic kidney disease or autosomal recessive polycystic kidney disease, lupus nephritis, or ANCA-associated vasculitis
- Indication for immunosuppressants as per the treating physician's judgment.
- Receiving cytotoxic therapy, immunosuppressive therapy, or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment.
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- Active malignancy aside from treated squamous cell or basal cell carcinoma of the skin.
- Use of co-interventional treatments (outlined in section 4.2 of the protocol) 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 of difficulty in voiding at screening
- History of severe hypersensitivity or contraindications to dapagliflozin
- Subject 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 investigation within 3 months prior to initial dosing.
- Donation or loss of 400 ml or more of blood within 8 weeks 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
- WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and up to 4 weeks after the last dose of study drug.
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Netherlands3 sites
Dept Internal Medicine, division of Nephrology Hospital Group Twente
Almelo, 7609 PP
Dept.of Nephrology, VU University Medical Center
Amsterdam, 1081 HV
Dept. Nephrology, University Medical Center Groningen
Groningen, 9713 GZ
Canada2 sites
Division of Nephrology University Health Network, University of Toronto
Toronto, Ontario, M5G 2C4
Nephrology Dept., Vancouver Coastal Health Research Institute
Vancouver, British Columbia, V5Z 1M9
Malaysia2 sites
Nephrology Unit, University Kebangsaan Malaysia
Kuala Lumpur, 5600
University Malaya Medical Centre, Ward 8TE
Kuala Lumpur, 59100
About this study
Official title: A Study to Assess the Renoprotective Effects of the SGLT2 Inhibitor Dapagliflozin in Non-Diabetic Patients With Proteinuria: a Randomized Double Blind 6-Weeks Cross-Over Trial
This study tests the hypothesis that dapagliflozin lowers proteinuria in patients with non-diabetic chronic kidney disease.
Read the detailed description
Despite optimal treatment with renin-angiotensin-aldosterone-system (RAAS) inhibitors, many patients with non-diabetic kidney disease show progressive kidney function loss, which is associated with high residual proteinuria. Novel treatment strategies are therefore required to further decrease proteinuria and to slow kidney function decline.
Dapagliflozin is a sodium-glucose transport (SGLT2) inhibitor and inhibits the reabsorption of glucose and sodium in the proximal tubule. The increased natriuresis following dapagliflozin administration normalizes tubuloglomerular feedback resulting in a reduction in intra-glomerular hypertension, which is in turn manifested by acute reversible reductions in glomerular filtration rate and albuminuria. Since many etiologies of non-diabetic nephropathy are characterized by intraglomerular hypertension, we hypothesize that dapagliflozin acutely decreases GFR and proteinuria in patients without diabetes at risk of progressive kidney function loss via a glucose independent hemodynamic mechanism.
- Conditions
- Chronic Kidney Diseases, Proteinuria
- Being tested
- Dapagliflozin 10mg
- Keywords
- chronic kidney disease, non diabetic
- Medical subject headings
- Renal Insufficiency, Chronic, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10mgDrug
Also called Placebo Matching Dapagliflozin 10mg
Tablet
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin 10mg Tablet, then Placebo | Experimental | Participants first received Dapagliflozin 10mg tablet for 6 weeks. After a washout period of 6 weeks, they then received Placebo tablet for 6 weeks (matching Dapagliflozin 10mg).
Dapagliflozin 10 mg: Green, plain, diamond shaped, film coated tablet (orally) Placebo: Green, plain, diamond shaped, film coated tablet. Does not contain active ingredient Receives: Drug: Dapagliflozin 10mg |
| Placebo, then Dapagliflozin | Placebo comparator | Participants first received Placebo tablet for 6 weeks. After a washout period of 6 weeks, they then received Dapagliflozin 10mg tablet for 6 weeks (matching Dapagliflozin 10mg).
Placebo: Green, plain, diamond shaped, film coated tablet. Does not contain active ingrediënt Dapagliflozin 10 mg: Green, plain, diamond shaped, film coated tablet (orally) Receives: Drug: Dapagliflozin 10mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 24-hr Proteinuria With Dapagliflozin for Six Weeks Relative to Placebo in Patients With Non-diabetic Kidney Disease and Proteinuria 500 mg/Day on Stable Angiotensin-converting Enzyme Inhibitor or Angiotensin II Receptor Blocker Treatment.
bioequivalence
Measured: 6 weeks
Secondary outcomes (10)
Effect of Dapagliflozin 10 mg/d Compared to Placebo on Glomerular Filtration Rate (GFR) Using Iohexol Clearance
bioequivalence
Measured: 6 weeks
Effect of Dapagliflozin 10 mg/d Compared to Placebo on Systolic/Diastolic Blood Pressure
bioequivalence
Measured: week 0, 3, 6, 12, 15, 18, 24
Effect of Dapagliflozin 10 mg/d Compared to Placebo on Body Weight
bioequivalence
Measured: week 0, 3, 6, 12, 15, 18, 24
Effect of Dapagliflozin 10 mg/d Compared to Placebo on 6-keto-Prostaglandin F1 Alpha/Creatinine Ratio
bioequivalence
Measured: Baseline, Week 6
Safety of Dapagliflozin vs. Placebo - the Number of Participatns With Hypoglycemic Events and/or Serious Adverse Events
safety
Measured: week 0-26
Effect of Dapagliflozin 10 mg/d Compared to Placebo on Adenosine/Creatinine Ratio
bioequivalence
Measured: Baseline, Week 6
Effect of Dapagliflozin 10 mg/d Compared to Placebo on Prostaglandin E2/Creatinine Ratio
bioequivalence
Measured: Baseline, Week 6
Effect of Dapagliflozin 10 mg/d Compared to Placebo on Thromboxane B2/Creatinine Ratio
bioequivalence
Measured: Baseline, Week 6
Effect of Dapagliflozin 10 mg/d Compared to Placebo on PGEM/Creatinine Ratio
bioequivalence
Measured: Baseline, Week 6
Effect of Dapagliflozin 10 mg/d Compared to Placebo on NTproBNP
bioequivalence
Measured: Baseline (week 0, week 12), Week 6 + 18 (pooled)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start12 Nov 2017
- Primary completion1 Nov 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A Randomized Double Blind 6-Weeks Cross-over
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hiddo Lambers Heerspink
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor-investigator, Hiddo Lambers Heerspink, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03190694
- Sponsor's protocol ID
- 2017003001
- Other IDs
- 2017-001090-16, 2017
- Acronym
- DIAMOND
- Status last verified
- Jan 2024
- First submitted
- 15 Jun 2017
- Last updated
- 17 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
van der Aart-van der Beek AB, Koomen JV, Dekkers CCJ, Barbour SJ, Boulton DW, Gansevoort RT, Greasley PJ, Abdul Gafor AH, Laverman GD, Li Q, Lim SK, Stevens J, Vervloet MG, Singh S, Cattran DC, Reich HN, Cherney DZI, Heerspink HJL. Evaluation of the Pharmacokinetics and Exposure-Response Relationship of Dapagliflozin in Patients without Diabetes and with Chronic Kidney Disease. Clin Pharmacokinet. 2021 Apr;60(4):517-525. doi: 10.1007/s40262-020-00956-1. Epub 2021 Feb 15.
PubMed 33587286Cherney DZI, Dekkers CCJ, Barbour SJ, Cattran D, Abdul Gafor AH, Greasley PJ, Laverman GD, Lim SK, Di Tanna GL, Reich HN, Vervloet MG, Wong MG, Gansevoort RT, Heerspink HJL; DIAMOND investigators. Effects of the SGLT2 inhibitor dapagliflozin on proteinuria in non-diabetic patients with chronic kidney disease (DIAMOND): a randomised, double-blind, crossover trial. Lancet Diabetes Endocrinol. 2020 Jul;8(7):582-593. doi: 10.1016/S2213-8587(20)30162-5.
PubMed 32559474
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Renoprotective Effects of the SGLT2 Inhibitor Dapagliflozin in Non-Diabetic Patients With Proteinuria: a Randomized Double Blind 6-Weeks Cross-Over Trial
- ClinicalTrials.gov ID
- NCT03190694
- Acronym / sponsor ID
- DIAMOND / 2017003001
- Conditions
- Chronic Kidney Diseases, Proteinuria
- Keywords
- chronic kidney disease, non diabetic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Hiddo Lambers HeerspinkUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 12 Nov 2017 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 19 Jun 2017 (actual)
- Results
- Posted 17 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study tests the hypothesis that dapagliflozin lowers proteinuria in patients with non-diabetic chronic kidney disease.
Detailed description
Despite optimal treatment with renin-angiotensin-aldosterone-system (RAAS) inhibitors, many patients with non-diabetic kidney disease show progressive kidney function loss, which is associated with high residual proteinuria. Novel treatment strategies are therefore required to further decrease proteinuria and to slow kidney function decline.
Dapagliflozin is a sodium-glucose transport (SGLT2) inhibitor and inhibits the reabsorption of glucose and sodium in the proximal tubule. The increased natriuresis following dapagliflozin administration normalizes tubuloglomerular feedback resulting in a reduction in intra-glomerular hypertension, which is in turn manifested by acute reversible reductions in glomerular filtration rate and albuminuria. Since many etiologies of non-diabetic nephropathy are characterized by intraglomerular hypertension, we hypothesize that dapagliflozin acutely decreases GFR and proteinuria in patients without diabetes at risk of progressive kidney function loss via a glucose independent hemodynamic mechanism.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A Randomized Double Blind 6-Weeks Cross-over
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin 10mg Tablet, then Placebo | Experimental | Drug: Dapagliflozin 10mgParticipants first received Dapagliflozin 10mg tablet for 6 weeks. After a washout period of 6 weeks, they then received Placebo tablet for 6 weeks (matching Dapagliflozin 10mg). Dapagliflozin 10 mg: Green, plain, diamond shaped, film coated tablet (orally) Placebo: Green, plain, diamond shaped, film coated tablet. Does not contain active ingredient |
| Placebo, then Dapagliflozin | Placebo comparator | Drug: Dapagliflozin 10mgParticipants first received Placebo tablet for 6 weeks. After a washout period of 6 weeks, they then received Dapagliflozin 10mg tablet for 6 weeks (matching Dapagliflozin 10mg). Placebo: Green, plain, diamond shaped, film coated tablet. Does not contain active ingrediënt Dapagliflozin 10 mg: Green, plain, diamond shaped, film coated tablet (orally) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥18 and ≤75 years
- Urinary protein excretion > 500 mg/g and ≤ 3500 mg/g in a 24-hr urine collection eGFR ≥ 25 mL/min/1.73m2
- On a stable dose of an ACEi or ARB for at least 4 weeks prior to randomization
- Willing to sign informed consent
- Women of Child-Bearing Potential (WOCBP):
Key exclusion criteria (24 listed)
- Diagnosis of type 1 or type 2 diabetes mellitus
- Urinary protein excretion > 3500 mg/day
- Peripheral Vascular Disease
- Autosomal dominant polycystic kidney disease or autosomal recessive polycystic kidney disease, lupus nephritis, or ANCA-associated vasculitis
- Indication for immunosuppressants as per the treating physician's judgment.
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 10mgAlso: Placebo Matching Dapagliflozin 10mgTablet | Drug | Dapagliflozin 10mg Tablet, then Placebo, Placebo, then Dapagliflozin |
Primary outcome
Change in 24-hr Proteinuria With Dapagliflozin for Six Weeks Relative to Placebo in Patients With Non-diabetic Kidney Disease and Proteinuria 500 mg/Day on Stable Angiotensin-converting Enzyme Inhibitor or Angiotensin II Receptor Blocker Treatment.
Time frame: 6 weeks
bioequivalence
10 secondary outcomes
Effect of Dapagliflozin 10 mg/d Compared to Placebo on Glomerular Filtration Rate (GFR) Using Iohexol Clearance
Time frame: 6 weeks
Effect of Dapagliflozin 10 mg/d Compared to Placebo on Systolic/Diastolic Blood Pressure
Time frame: week 0, 3, 6, 12, 15, 18, 24
Effect of Dapagliflozin 10 mg/d Compared to Placebo on Body Weight
Time frame: week 0, 3, 6, 12, 15, 18, 24
Effect of Dapagliflozin 10 mg/d Compared to Placebo on 6-keto-Prostaglandin F1 Alpha/Creatinine Ratio
Time frame: Baseline, Week 6
Safety of Dapagliflozin vs. Placebo - the Number of Participatns With Hypoglycemic Events and/or Serious Adverse Events
Time frame: week 0-26
Effect of Dapagliflozin 10 mg/d Compared to Placebo on Adenosine/Creatinine Ratio
Time frame: Baseline, Week 6
Effect of Dapagliflozin 10 mg/d Compared to Placebo on Prostaglandin E2/Creatinine Ratio
Time frame: Baseline, Week 6
Effect of Dapagliflozin 10 mg/d Compared to Placebo on Thromboxane B2/Creatinine Ratio
Time frame: Baseline, Week 6
Effect of Dapagliflozin 10 mg/d Compared to Placebo on PGEM/Creatinine Ratio
Time frame: Baseline, Week 6
Effect of Dapagliflozin 10 mg/d Compared to Placebo on NTproBNP
Time frame: Baseline (week 0, week 12), Week 6 + 18 (pooled)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33587286van der Aart-van der Beek AB, Koomen JV, Dekkers CCJ, Barbour SJ, Boulton DW, Gansevoort RT, Greasley PJ, Abdul Gafor AH, Laverman GD, Li Q, Lim SK, Stevens J, Vervloet MG, Singh S, Cattran DC, Reich HN, Cherney DZI, Heerspink HJL. Evaluation of the Pharmacokinetics and Exposure-Response Relationship of Dapagliflozin in Patients without Diabetes and with Chronic Kidney Disease. Clin Pharmacokinet. 2021 Apr;60(4):517-525. doi: 10.1007/s40262-020-00956-1. Epub 2021 Feb 15.
- Derived from this study: PubMed 32559474Cherney DZI, Dekkers CCJ, Barbour SJ, Cattran D, Abdul Gafor AH, Greasley PJ, Laverman GD, Lim SK, Di Tanna GL, Reich HN, Vervloet MG, Wong MG, Gansevoort RT, Heerspink HJL; DIAMOND investigators. Effects of the SGLT2 inhibitor dapagliflozin on proteinuria in non-diabetic patients with chronic kidney disease (DIAMOND): a randomised, double-blind, crossover trial. Lancet Diabetes Endocrinol. 2020 Jul;8(7):582-593. doi: 10.1016/S2213-8587(20)30162-5.
- Individual participant dataSharing planned: Undecided
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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.
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dapagliflozin 10mg in people with Chronic Kidney Diseases and Proteinuria, run by Hiddo Lambers Heerspink at 7 sites in 3 countries.
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 9 inclusion and 24 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: finished, as of the sponsor's last update on 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Netherlands, Canada, Malaysia. 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?
Yes. Results are posted in the registry (first posted 17 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in 24-hr Proteinuria With Dapagliflozin for Six Weeks Relative to Placebo in Patients With Non-diabetic Kidney Disease and Proteinuria 500 mg/Day on Stable Angiotensin-converting Enzyme Inhibitor or Angiotensin II Receptor Blocker Treatment. (time frame: 6 weeks). 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 NCT03190694, which also lists 2 linked publications.
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 Jun 2024.