Diabetic Kidney DiseasePhase 2NCT04170543
A Phase 2b Diabetic Kidney Disease Study
A Phase 2 study testing MEDI3506 and Dapagliflozin in people with Diabetic Kidney Disease, run by AstraZeneca at 97 sites in 7 countries.
Trial summary
A Phase 2b Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of MEDI3506 in Subjects with Diabetic Kidney Disease Read more about this study
- Who is it for?
- Ages 18 to 101 years
- Conditions the study is for
- Diabetic Kidney Disease
- What is being tested?
- MEDI3506 and Dapagliflozin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 609 participants
- Where
- 97 sitesin 7 countries
- Study dates
- 18 Nov 2019to 16 May 2023
- 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 101 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult men or women ≥ 18 years of age.
- Diabetic kidney disease DKD defined as:
- diagnosis of T2DM
- eGFR 25-75 mL/min/1.73 m2
- UACR 100-3000 mg albumin/g creatinine
- BP ≤ 150/100 mmHg
- Stable dose of ACEi or ARB Key Exclusion Criteria
- 1. Serum potassium > 5.5 mmol/L 2. Significant hepatic disease 3. Hemoglobin A1c > 10.5 % 4. B-type natriuretic peptide level > 200 pg/mL 5. History of clinically significant heart disease 6. Anticipated dialysis or renal transplantation within 1 year 7. History of underlying condition that predisposes the subject to infections 8. Significant infection (viral, bacterial, or fungal) 9. Amputation due to peripheral artery disease 10. Subjects with a positive diagnostic nucleic acid test for SARS-CoV-2 11. Pregnancy, breastfeeding or intention to become pregnant during the course of the study, 12. Any other medical condition or clinically relevant abnormal findings in physical examination, laboratory results, or electrocardiogram (ECG) during screening that, in the opinion of the investigator, may compromise the safety of the subject in the study, reduce the subject's ability to participate in the study, or interfere with evaluation of the investigational product
Who cannot join
None listed.
Trial locations and contacts
97 sites in 7 countries.
97 sites in 7 countries
United States49 sites
Research Site
Alhambra, California, 91801
Research Site
Atlanta, Georgia, 30338
Research Site
Berlin, New Jersey, 08009
Research Site
Bethlehem, Pennsylvania, 18017
Research Site
Birmingham, Alabama, 35209
Research Site
Burke, Virginia, 22015
Research Site
Charlotte, North Carolina, 28204
Research Site
Chicago, Illinois, 60607
Research Site
Chicago, Illinois, 60643
Research Site
Columbia, South Carolina, 29203
Research Site
Cypress, Texas, 77429
Research Site
East Providence, Rhode Island, 02915
Research Site
Fleming Island, Florida, 32003
Research Site
Flint, Michigan, 48504
Research Site
Glendale, California, 91204
Research Site
Granada Hills, California, 91344
Research Site
Greensboro, North Carolina, 27408
Research Site
Greenville, North Carolina, 27834
Research Site
Henderson, Nevada, 89014
Research Site
Hialeah, Florida, 33016
Research Site
Honolulu, Hawaii, 96814
Research Site
Houston, Texas, 77004
Research Site
Houston, Texas, 77079
Research Site
Huntington Park, California, 90255
Research Site
Huntsville, Alabama, 35805
Research Site
Iowa City, Iowa, 52242
Research Site
Jacksonville, Florida, 32204
Research Site
Katy, Texas, 77450
Research Site
Las Vegas, Nevada, 89129
Research Site
Manhattan, Kansas, 66502
Research Site
Maumee, Ohio, 43537
Research Site
Memphis, Tennessee, 38119
Research Site
Mesa, Arizona, 85210
Research Site
Miami, Florida, 33015
Research Site
Morehead City, North Carolina, 28557
Research Site
Morgantown, West Virginia, 26506
Research Site
Northridge, California, 91324
Research Site
Oklahoma City, Oklahoma, 73116
Research Site
Sacramento, California, 95821
Research Site
San Antonio, Texas, 78212
Research Site
San Antonio, Texas, 78229
Research Site
San Antonio, Texas, 78251
Research Site
San Diego, California, 92123
Research Site
San Dimas, California, 91773
Research Site
St. George, Utah, 84790
Research Site
Tacoma, Washington, 98405
Research Site
Topeka, Kansas, 66606
Research Site
Vacaville, California, 95687
Research Site
Wichita, Kansas, 67214
Argentina15 sites
Research Site
Buenos Aires, 1425DES
Research Site
Buenos Aires, C1056ABJ
Research Site
Buenos Aires, C1429BWN
Research Site
Caba, C1128AAF
Research Site
CABA, C1120AAC
Research Site
CABA, C1425AGC
Research Site
Córdoba, X5000AAW
Research Site
Corrientes, W3400AMZ
Research Site
Mar del Plata, 7600
Research Site
Pergamino, B2700LDK
Research Site
Ramos Mejía, B1704ETD
Research Site
Rosario, S2000DNM
Research Site
San Luis, D5700CTA
Research Site
San Nicolás, B2900DMH
Research Site
San Vicente, 5006
Japan11 sites
Research Site
Chūōku, 103-0027
Research Site
Fukuoka, 815-8555
Research Site
Ise-shi, 516-8512
Research Site
Kisarazu-shi, 292-8535
Research Site
Koshigaya-shi, 343-8577
Research Site
Nagano, 388-8004
Research Site
Nagoya, 451-8511
Research Site
Nishinomiya-Shi, 662-0918
Research Site
Osaka, 530-0001
Research Site
Osaka, 558-8558
Research Site
Sayama-Shi
Canada7 sites
Research Site
Brampton, Ontario, L6S 0S9
Research Site
Brampton, Ontario, L6T 0G1
Research Site
Calgary, Alberta, T2H 2G4
Research Site
Concord, Ontario, L4K 4M2
Research Site
Etobicoke, Ontario, M9R 4E1
Research Site
Red Deer, Alberta, T4N 6V7
Research Site
Toronto, Ontario, M4G 3E8
Chile7 sites
Research Site
Concepción
Research Site
Ñuñoa, 8520398
Research Site
Santiago, 7500021
Research Site
Santiago, 7500710
Research Site
Santiago, 8320000
Research Site
Santiago
Research Site
Victoria
South Korea7 sites
Research Site
Gangnam-Gu, 6273
Research Site
Goyang-si, 10444
Research Site
Jongno-gu, 110-746
Research Site
Seongbuk-Gu, 02841
Research Site
Seoul, 06351
Research Site
Suwon, 16499
Research Site
Wŏnju, 26426
About this study
Official title: A Phase 2b Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of MEDI3506 in Subjects With Diabetic Kidney Disease
A Phase 2b Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of MEDI3506 in Subjects with Diabetic Kidney Disease
Read the detailed description
This is a Phase 2b, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, PK, and immunogenicity of MEDI3506 on top of standard of care, including angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) and dapagliflozin in adult subjects with diabetic kidney disease, defined as subjects with type 2 diabetes mellitus (T2DM) and an estimated glomerular filtration rate (eGFR) of 25-75 mL/min/1.73 m2 with a UACR in the range of 100-3000 mg/g, who meet all eligibility criteria. Approximately 565 subjects, among multiple countries will be randomized to MEDI3506 dose 1, 2, 3 or dose 4, or placebo during a treatment period of 24 weeks. All subjects will receive Dapagliflozin daily, as administered orally from Day 85 to Day 168. The primary objective is to evaluate the effect of MEDI3506 on albuminuria in subjects with DKD. Secondary objectives include evaluating safety, PK and the incidence of ADA during the treatment period.
- Conditions
- Diabetic Kidney Disease
- Being tested
- MEDI3506, Placebo, Dapagliflozin
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI3506Drug
Dose 1, Dose 2, Dose 3, Dose 4
PlaceboDrug
Placebo
DapagliflozinDrug
Dapagliflozin 10 mg
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | MEDI3506 Dose 1 plus Dapagliflozin (Day 85 to Day 168). Receives: Drug: MEDI3506; Drug: Dapagliflozin |
| Group 2 | Experimental | MEDI3506 Dose 2 plus Dapagliflozin (Day 85 to Day 168). Receives: Drug: MEDI3506; Drug: Dapagliflozin |
| Group 3 | Experimental | MEDI3506 Dose 3 plus Dapagliflozin (Day 85 to Day 168). Receives: Drug: MEDI3506; Drug: Dapagliflozin |
| Group 4 | Experimental | MEDI3506 Dose 4 plus Dapagliflozin (Day 85 to Day 168). Receives: Drug: MEDI3506; Drug: Dapagliflozin |
| Group 5 | Placebo comparator | Placebo (volume matched) plus Dapagliflozin (Day 85 to Day 168). Receives: Drug: Placebo; Drug: Dapagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline to Day 169 (Week 24) in UACR - Per Protocol Population
UACR values are collected as triplicates at baseline and at each CSP planned visit. For each triplicate, the UACR are averaged with geometric mean.
Baseline is defined as the geometric mean of UACR measurements prior to first dose of study treatment.
For the intercurrent events, if a subject is lost to follow-up (EOT), discontinues treatment due to AE, or uses prohibited medication, the UACR data are treated as missing on or after the event and no imputation is performed.
The LS means of percent change and difference in percent change, corresponding 90% confidence intervals are calculated based on a mixed model with repeated measures (MMRM) of log (UACR post-baseline/UACR baseline) as the response, adjusting for fixed effects of treatment, visit, and treatment-by-visit interaction, SGLT2i, region (Japan or ROW), baseline log UACR, and baseline log UACR-by-visit interaction.
The MMRM includes UACR values at protocol specified visits from baseline up to Day 169.
Measured: From baseline to Day 169
Secondary outcomes (9)
Percent Change From Baseline to Day 85 (Week 12) in UACR - Per Protocol Population
UACR values are collected as triplicates at baseline and at each CSP planned visit. For each triplicate, the UACR are averaged with geometric mean.
Baseline is defined as the geometric mean of UACR measurements prior to first dose of study treatment.
For the intercurrent events, if a subject is lost to follow-up (EOT), discontinues treatment due to AE, or uses prohibited medication, the UACR data are treated as missing on or after the event and no imputation is performed.
The LS means of percent change and difference in percent change, corresponding 90% confidence intervals are calculated based on a mixed model with repeated measures (MMRM) of log (UACR post-baseline/UACR baseline) as the response, adjusting for fixed effects of treatment, visit, and treatment-by-visit interaction, SGLT2i, region (Japan or ROW), baseline log UACR, and baseline log UACR-by-visit interaction.
The MMRM includes UACR values at protocol specified visits from baseline up to Day 169.
Measured: From baseline to Day 85
Percent Change From Day 85 (Week 12) to Day 169 (Week 24) in UACR - Per Protocol Population
UACR values are collected as triplicates at baseline and at each CSP planned visit. For each triplicate, the UACR are averaged with geometric mean.
Baseline is defined as the geometric mean of UACR measurements prior to first dose of study treatment.
For the intercurrent events, if a subject is lost to follow-up (EOT), discontinues treatment due to AE, or uses prohibited medication, the UACR data are treated as missing on or after the event and no imputation is performed.
The LS means of percent change and difference in percent change, corresponding 90% confidence intervals are calculated based on a mixed model with repeated measures (MMRM) of log (UACR post-baseline/UACR baseline) as the response, adjusting for fixed effects of treatment, visit, and treatment-by-visit interaction, SGLT2i, region (Japan or ROW), baseline log UACR, and baseline log UACR-by-visit interaction.
The MMRM includes UACR values at protocol specified visits from Day 85 up to Day 169.
Measured: From Day 85 to Day 169
Proportion of Subjects With Reduction in UACR at Day 169 (Week 24) - Per Protocol Population
UACR values are collected as triplicates at baseline and at each CSP planned visit. For each triplicate, the UACR are averaged with geometric mean.
Baseline is defined as the geometric mean of UACR measurements prior to first dose of study treatment.
Only participants with values at Baseline and Day 169 are included.
Measured: Baseline and Day 169
Percent Change From Baseline to Day 169 (Week 24) in UACR - Full Analysis Population
UACR values are collected as triplicates at baseline and at each CSP planned visit. For each triplicate, the UACR are averaged with geometric mean.
Baseline is defined as the geometric mean of UACR measurements prior to first dose of study treatment.
For the intercurrent events, if a subject is lost to follow-up (EOT), discontinues treatment due to AE, or uses prohibited medication, the UACR data are treated as missing on or after the event and no imputation is performed.
The LS means of percent change and difference in percent change, corresponding 90% confidence intervals are calculated based on a mixed model with repeated measures (MMRM) of log (UACR post-baseline/UACR baseline) as the response, adjusting for fixed effects of treatment, visit, and treatment-by-visit interaction, SGLT2i, region (Japan or ROW), baseline log UACR, and baseline log UACR-by-visit interaction.
The MMRM includes UACR values at protocol specified visits from baseline up to Day 169.
Measured: From baseline to Day 169
Percent Change From Baseline to Day 85 (Week 12) in UACR - Full Analysis Population
UACR values are collected as triplicates at baseline and at each CSP planned visit. For each triplicate, the UACR are averaged with geometric mean.
Baseline is defined as the geometric mean of UACR measurements prior to first dose of study treatment.
For the intercurrent events, if a subject is lost to follow-up (EOT), discontinues treatment due to AE, or uses prohibited medication, the UACR data are treated as missing on or after the event and no imputation is performed.
The LS means of percent change and difference in percent change, corresponding 90% confidence intervals are calculated based on a mixed model with repeated measures (MMRM) of log (UACR post-baseline/UACR baseline) as the response, adjusting for fixed effects of treatment, visit, and treatment-by-visit interaction, SGLT2i, region (Japan or ROW), baseline log UACR, and baseline log UACR-by-visit interaction.
The MMRM includes UACR values at protocol specified visits from baseline up to Day 169.
Measured: From baseline to Day 85
Proportion of Subjects With Reduction in UACR at Day 169 (Week 24) - Full Analysis Population
UACR values are collected as triplicates at baseline and at each CSP planned visit. For each triplicate, the UACR are averaged with geometric mean.
Baseline is defined as the geometric mean of UACR measurements prior to first dose of study treatment.
Only participants with values at Baseline and Day 169 are included.
Measured: Baseline and Day 169
Immunogenicity of MEDI3506 - PK Analysis Population
ADA prevalence: number of participants ADA positive (ADA+) at baseline and/or post-baseline.
Treatment-induced ADA+: ADA not detected or missing at baseline and at least one post-baseline ADA+.
Treatment-boosted ADA+: ADA+ at baseline and baseline titre is boosted by ≥ 4-fold increase at ≥ 1 post-baseline time point.
Treatment-emergent ADA+ (TE-ADA + or ADA incidence): Treatment-induced ADA+ OR and Treatment-boosted ADA+.
Measured: Day 1 to Day 230
Asymptomatic Participants Tested Positive for COVID-19 During the Study - Safety Analysis Population
Participants were tested for COVID-19 during the course of the study. Descriptive analysis of asymptomatic participants tested positive for COVID-19 during the study.
Measured: Day 1 to Day 230
Treatment-emergent Adverse Events and Treatment-emergent Serious Adverse Events Among COVID-19 Positive Participants - Safety Analysis Population
For participants tested positive for COVID-19 during the intervention and follow-up periods, this analysis provides:
- the number and proportion of subjects with any treatment-emergent adverse event
- the number and proportion of subjects with any treatment-emergent serious adverse event
Measured: Day 1 to Day 230
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start18 Nov 2019
- Primary completion16 May 2023
- Study completion16 May 2023
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 Diabetic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Model description
- Eligible subjects will be randomized to receive MEDI3506 or placebo as follows: Group 1: MEDI3506 Dose 1. Group 2: MEDI3506 Dose 2. Group 3: MEDI3506 Dose 3 Group 4: MEDI3506 Dose 4 Group 5: Placebo (volume matched) All subjects will receive Dapa from Day 85 to Day 168.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 609 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04170543
- Sponsor's protocol ID
- D9183C00001
- Status last verified
- Jul 2024
- First submitted
- 18 Nov 2019
- Last updated
- 10 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared
Publications
Hofherr A, Maki-Petaja K, Selvarajah V, Grice D, Bartesaghi S, Jimenez E, Pecoits-Filho R, Heerspink HJL. Inhibition of IL-33 in Diabetic Kidney Disease: A Randomized, Placebo-Controlled Phase 2b Trial. J Am Soc Nephrol. 2026 May 1;37(5):1022-1033. doi: 10.1681/ASN.0000000966. Epub 2025 Dec 5.
PubMed 41563367Hofherr A, Liarte Marin E, Musial B, Seth A, Slidel T, Conway J, Baker D, Hansen PBL, Challis B, Bartesaghi S, Bhat M, Pecoits-Filho R, Tu X, Selvarajah V, Woollard K, Heerspink HJL. Inhibition of Interleukin-33 to Reduce Glomerular Endothelial Inflammation in Diabetic Kidney Disease. Kidney Int Rep. 2024 Mar 18;9(6):1876-1891. doi: 10.1016/j.ekir.2024.03.009. eCollection 2024 Jun.
PubMed 38899206
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of MEDI3506 in Subjects With Diabetic Kidney Disease
- ClinicalTrials.gov ID
- NCT04170543
- Acronym / sponsor ID
- D9183C00001
- Conditions
- Diabetic Kidney Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 609 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- 16 May 2023 (actual)
- Study completion
- 16 May 2023 (actual)
- First posted
- 20 Nov 2019 (actual)
- Results
- Posted 10 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 2b Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of MEDI3506 in Subjects with Diabetic Kidney Disease
Detailed description
This is a Phase 2b, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, PK, and immunogenicity of MEDI3506 on top of standard of care, including angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) and dapagliflozin in adult subjects with diabetic kidney disease, defined as subjects with type 2 diabetes mellitus (T2DM) and an estimated glomerular filtration rate (eGFR) of 25-75 mL/min/1.73 m2 with a UACR in the range of 100-3000 mg/g, who meet all eligibility criteria. Approximately 565 subjects, among multiple countries will be randomized to MEDI3506 dose 1, 2, 3 or dose 4, or placebo during a treatment period of 24 weeks. All subjects will receive Dapagliflozin daily, as administered orally from Day 85 to Day 168. The primary objective is to evaluate the effect of MEDI3506 on albuminuria in subjects with DKD. Secondary objectives include evaluating safety, PK and the incidence of ADA during the treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- Eligible subjects will be randomized to receive MEDI3506 or placebo as follows: Group 1: MEDI3506 Dose 1. Group 2: MEDI3506 Dose 2. Group 3: MEDI3506 Dose 3 Group 4: MEDI3506 Dose 4 Group 5: Placebo (volume matched) All subjects will receive Dapa from Day 85 to Day 168.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: MEDI3506, Drug: DapagliflozinMEDI3506 Dose 1 plus Dapagliflozin (Day 85 to Day 168). |
| Group 2 | Experimental | Drug: MEDI3506, Drug: DapagliflozinMEDI3506 Dose 2 plus Dapagliflozin (Day 85 to Day 168). |
| Group 3 | Experimental | Drug: MEDI3506, Drug: DapagliflozinMEDI3506 Dose 3 plus Dapagliflozin (Day 85 to Day 168). |
| Group 4 | Experimental | Drug: MEDI3506, Drug: DapagliflozinMEDI3506 Dose 4 plus Dapagliflozin (Day 85 to Day 168). |
| Group 5 | Placebo comparator | Drug: Placebo, Drug: DapagliflozinPlacebo (volume matched) plus Dapagliflozin (Day 85 to Day 168). |
Who may qualify
- Ages
- 18 to 101 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult men or women ≥ 18 years of age.
- Diabetic kidney disease DKD defined as:
- BP ≤ 150/100 mmHg
- Stable dose of ACEi or ARB Key Exclusion Criteria
- 1. Serum potassium > 5.5 mmol/L 2. Significant hepatic disease 3. Hemoglobin A1c > 10.5 % 4. B-type natriuretic peptide level > 200 pg/mL 5. History of clinically significant heart disease 6. Anticipated dialysis or renal transplantation within 1 year 7. History of underlying condition that predisposes the subject to infections 8. Significant infection (viral, bacterial, or fungal) 9. Amputation due to peripheral artery disease 10. Subjects with a positive diagnostic nucleic acid test for SARS-CoV-2 11. Pregnancy, breastfeeding or intention to become pregnant during the course of the study, 12. Any other medical condition or clinically relevant abnormal findings in physical examination, laboratory results, or electrocardiogram (ECG) during screening that, in the opinion of the investigator, may compromise the safety of the subject in the study, reduce the subject's ability to participate in the study, or interfere with evaluation of the investigational product
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| MEDI3506Dose 1, Dose 2, Dose 3, Dose 4 | Drug | Group 1, Group 2, Group 3, Group 4 |
| PlaceboPlacebo | Drug | Group 5 |
| DapagliflozinDapagliflozin 10 mg | Drug | Group 1, Group 2, Group 3, Group 4, Group 5 |
Primary outcome
Percent Change From Baseline to Day 169 (Week 24) in UACR - Per Protocol Population
Time frame: From baseline to Day 169
UACR values are collected as triplicates at baseline and at each CSP planned visit. For each triplicate, the UACR are averaged with geometric mean. Baseline is defined as the geometric mean of UACR measurements prior to first dose of study treatment. For the intercurrent events, if a subject is lost to follow-up (EOT), discontinues treatment due to AE, or uses prohibited medication, the UACR data are treated as missing on or after the event and no imputation is performed. The LS means of percent change and difference in percent change, corresponding 90% confidence intervals are calculated based on a mixed model with repeated measures (MMRM) of log (UACR post-baseline/UACR baseline) as the response, adjusting for fixed effects of treatment, visit, and treatment-by-visit interaction, SGLT2i, region (Japan or ROW), baseline log UACR, and baseline log UACR-by-visit interaction. The MMRM includes UACR values at protocol specified visits from baseline up to Day 169.
9 secondary outcomes
Percent Change From Baseline to Day 85 (Week 12) in UACR - Per Protocol Population
Time frame: From baseline to Day 85
Percent Change From Day 85 (Week 12) to Day 169 (Week 24) in UACR - Per Protocol Population
Time frame: From Day 85 to Day 169
Proportion of Subjects With Reduction in UACR at Day 169 (Week 24) - Per Protocol Population
Time frame: Baseline and Day 169
Percent Change From Baseline to Day 169 (Week 24) in UACR - Full Analysis Population
Time frame: From baseline to Day 169
Percent Change From Baseline to Day 85 (Week 12) in UACR - Full Analysis Population
Time frame: From baseline to Day 85
Proportion of Subjects With Reduction in UACR at Day 169 (Week 24) - Full Analysis Population
Time frame: Baseline and Day 169
Immunogenicity of MEDI3506 - PK Analysis Population
Time frame: Day 1 to Day 230
Asymptomatic Participants Tested Positive for COVID-19 During the Study - Safety Analysis Population
Time frame: Day 1 to Day 230
Treatment-emergent Adverse Events and Treatment-emergent Serious Adverse Events Among COVID-19 Positive Participants - Safety Analysis Population
Time frame: Day 1 to Day 230
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41563367Hofherr A, Maki-Petaja K, Selvarajah V, Grice D, Bartesaghi S, Jimenez E, Pecoits-Filho R, Heerspink HJL. Inhibition of IL-33 in Diabetic Kidney Disease: A Randomized, Placebo-Controlled Phase 2b Trial. J Am Soc Nephrol. 2026 May 1;37(5):1022-1033. doi: 10.1681/ASN.0000000966. Epub 2025 Dec 5.
- Derived from this study: PubMed 38899206Hofherr A, Liarte Marin E, Musial B, Seth A, Slidel T, Conway J, Baker D, Hansen PBL, Challis B, Bartesaghi S, Bhat M, Pecoits-Filho R, Tu X, Selvarajah V, Woollard K, Heerspink HJL. Inhibition of Interleukin-33 to Reduce Glomerular Endothelial Inflammation in Diabetic Kidney Disease. Kidney Int Rep. 2024 Mar 18;9(6):1876-1891. doi: 10.1016/j.ekir.2024.03.009. eCollection 2024 Jun.
- D9183C00001\_Redacted\_CSPLink provided by the sponsor.
- D9183C00001\_Redacted\_CSR\_SynopsisLink provided by the sponsor.
- D9183C00001\_Redacted\_SAPLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared
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Mitigating DKA in Type 1 Diabetes for Safe Use of SGLT Inhibitors Using Dual Continuous Ketone and Glucose Monitoring.
Type 1 Diabetes Mellitus, Chronic Kidney Disease (CKD) With Diabetes Mellitus (DM)
Not yet recruitingObservational study
Impact of AI-Based Breath Ammonia Kidney Function Results on Clinical Pharmacist Medication Recommendations
Diabetes Mellitus, Type 2, Diabetic Nephropathies
Not yet recruitingPhase 4
Modality Choice Before and After Failure for the Treatment of Painful Diabetic Neuropathy
Painful Diabetic Neuropathy (PDN), Diabetic Nephropathies
Not yet recruitingPhase 2
dApagliflozin SC0062 and Prevention of Renal Injury; a Randomized Evaluation
Type 1 Diabetes Mellitus With Diabetic Nephropathy
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.
97 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MEDI3506 and Dapagliflozin in people with Diabetic Kidney Disease, run by AstraZeneca at 97 sites in 7 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 8 inclusion and 0 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 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 97 sites in United States, Argentina, Japan, Canada, Chile and 2 more countries. 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 10 Jul 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?
Percent Change From Baseline to Day 169 (Week 24) in UACR - Per Protocol Population (time frame: From baseline to Day 169). 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 NCT04170543, 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 10 Jul 2024.