Trial · NCT04170543
A Phase 2b Diabetic Kidney Disease Study
NCT04170543, Phase 2, Completed, AstraZeneca; results first posted 2024-07-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase 2b Diabetic Kidney Disease Study. Trials, record NCT04170543. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04170543
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 2b Diabetic Kidney Disease Study
- NCT number
- NCT04170543
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 609 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Diabetic Kidney Disease
- Interventions
- MEDI3506, Placebo, Dapagliflozin
- First posted
- 2019-11-20
- Last updated
- 2024-07-10
- Results first posted
- 2024-07-10
- Limitations and caveats
41 randomized participants were excluded from analysis populations in order to avoid heterogeneity in the data (bias, etc.) :~* 2 participants did not received any IP~* 24 participants were enrolled in phase 2a without having the possibility to be enrolled in phase 2b~* 15 participants were randomized in a site with GCP breach (inability to confirm the validity of the data reported)~These 41 participants are excluded from Baseline characteristics (558 participants).
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline to Day 169 (Week 24) in UACR - Per Protocol Population | 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. |
| Secondary | Percent Change From Baseline to Day 85 (Week 12) in UACR - Per Protocol Population | From baseline to Day 85 | 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. |
| Secondary | Percent Change From Day 85 (Week 12) to Day 169 (Week 24) in UACR - Per Protocol Population | From Day 85 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 Day 85 up to Day 169. |
| Secondary | Proportion of Subjects With Reduction in UACR at Day 169 (Week 24) - Per Protocol Population | Baseline and 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. Only participants with values at Baseline and Day 169 are included. |
| Secondary | Percent Change From Baseline to Day 169 (Week 24) in UACR - Full Analysis Population | 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. |
| Secondary | Percent Change From Baseline to Day 85 (Week 12) in UACR - Full Analysis Population | From baseline to Day 85 | 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. |
| Secondary | Proportion of Subjects With Reduction in UACR at Day 169 (Week 24) - Full Analysis Population | Baseline and 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. Only participants with values at Baseline and Day 169 are included. |
| Secondary | Immunogenicity of MEDI3506 - PK Analysis Population | Day 1 to Day 230 | 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+. |
| Secondary | Asymptomatic Participants Tested Positive for COVID-19 During the Study - Safety Analysis Population | Day 1 to Day 230 | 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. |
| Secondary | Treatment-emergent Adverse Events and Treatment-emergent Serious Adverse Events Among COVID-19 Positive Participants - Safety Analysis Population | Day 1 to Day 230 | 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 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline to Day 169 (Week 24) in UACR - Per Protocol Population | From baseline to Day 169 | Per Protocol Population:~All randomized participants who received any study drug and did not violate any relevant important protocol deviations affecting the primary efficacy endpoint. | Percentage change from baseline | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline to Day 85 (Week 12) in UACR - Per Protocol Population | From baseline to Day 85 | Per Protocol Population:~All randomized participants who received any study drug and did not violate any relevant important protocol deviations affecting the primary efficacy endpoint. | Percentage change from baseline | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Day 85 (Week 12) to Day 169 (Week 24) in UACR - Per Protocol Population | From Day 85 to Day 169 | Per Protocol Population:~All randomized participants who received any study drug and did not violate any relevant important protocol deviations affecting the primary efficacy endpoint. | Percentage change from baseline | LEAST_SQUARES_MEAN |
| SECONDARY | Proportion of Subjects With Reduction in UACR at Day 169 (Week 24) - Per Protocol Population | Baseline and Day 169 | Per Protocol Population:~All randomized participants who received any study drug and did not violate any relevant important protocol deviations affecting the primary efficacy endpoint. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percent Change From Baseline to Day 169 (Week 24) in UACR - Full Analysis Population | From baseline to Day 169 | Full Analysis Population:~All randomized participants who received any study drug. | Percentage change from baseline | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline to Day 85 (Week 12) in UACR - Full Analysis Population | From baseline to Day 85 | Full Analysis Population:~All randomized participants who received any study drug. | Percentage change from baseline | LEAST_SQUARES_MEAN |
| SECONDARY | Proportion of Subjects With Reduction in UACR at Day 169 (Week 24) - Full Analysis Population | Baseline and Day 169 | Full Analysis Population:~All randomized participants who received any study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Immunogenicity of MEDI3506 - PK Analysis Population | Day 1 to Day 230 | PK Analysis Population:~All subjects who are randomized and receive any study drug who have at least one detectable MEDI3506 serum concentration measurement post-treatment. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Plasma Concentration of MEDI3506 - PK Analysis Population | Day 1, Day 29, Day 85 and Day 169 | PK Analysis Population:~All subjects who are randomized and receive any study drug who have at least one detectable MEDI3506 serum concentration measurement post-treatment. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Asymptomatic Participants Tested Positive for COVID-19 During the Study - Safety Analysis Population | Day 1 to Day 230 | Safety Analysis Population:~All randomized participants who received any study drug.~Subset of participants tested positive for COVID-19 during the study. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group105
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline to Day 169 (Week 24) in UACR - Per Protocol Population | Placebo | -14.82 | 90% Confidence Interval -27.05 to -0.53 | Percentage change from baseline | |
| Percent Change From Baseline to Day 169 (Week 24) in UACR - Per Protocol Population | MEDI3506 30 mg | -17.25 | 90% Confidence Interval -30.69 to -1.19 | Percentage change from baseline | |
| Percent Change From Baseline to Day 169 (Week 24) in UACR - Per Protocol Population | MEDI3506 60 mg | -31.45 | 90% Confidence Interval -42.54 to -18.21 | Percentage change from baseline | |
| Percent Change From Baseline to Day 169 (Week 24) in UACR - Per Protocol Population | MEDI3506 120 mg | -29.70 | 90% Confidence Interval -41.61 to -15.37 | Percentage change from baseline | |
| Percent Change From Baseline to Day 169 (Week 24) in UACR - Per Protocol Population | MEDI3506 300 mg | -20.96 | 90% Confidence Interval -31.32 to -9.04 | Percentage change from baseline | |
| Percent Change From Baseline to Day 85 (Week 12) in UACR - Per Protocol Population | Placebo | 21.60 | 90% Confidence Interval 7.39 to 37.70 | Percentage change from baseline | |
| Percent Change From Baseline to Day 85 (Week 12) in UACR - Per Protocol Population | MEDI3506 30 mg | 5.77 | 90% Confidence Interval -8.00 to 21.60 | Percentage change from baseline | |
| Percent Change From Baseline to Day 85 (Week 12) in UACR - Per Protocol Population | MEDI3506 60 mg | -9.66 | 90% Confidence Interval -21.46 to 3.91 | Percentage change from baseline | |
| Percent Change From Baseline to Day 85 (Week 12) in UACR - Per Protocol Population | MEDI3506 120 mg | -0.53 | 90% Confidence Interval -14.10 to 15.18 | Percentage change from baseline | |
| Percent Change From Baseline to Day 85 (Week 12) in UACR - Per Protocol Population | MEDI3506 300 mg | 2.69 | 90% Confidence Interval -8.32 to 15.01 | Percentage change from baseline |
1 to 10 of 105Source ClinicalTrials.gov
See all 105 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 147 | |
| Overall Study | STARTED | MEDI3506 30 mg | 96 | |
| Overall Study | STARTED | MEDI3506 60 mg | 101 | |
| Overall Study | STARTED | MEDI3506 120 mg | 95 | |
| Overall Study | STARTED | MEDI3506 300 mg | 160 | |
| Overall Study | COMPLETED | Placebo | 99 | |
| Overall Study | COMPLETED | MEDI3506 30 mg | 70 | |
| Overall Study | COMPLETED | MEDI3506 60 mg | 70 | |
| Overall Study | COMPLETED | MEDI3506 120 mg | 68 | |
| Overall Study | COMPLETED | MEDI3506 300 mg | 120 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events1,580
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Atrial fibrillation | Cardiac disorders | Placebo | 0 | 133 | 0 |
| other | Atrial fibrillation | Cardiac disorders | MEDI3506 30 mg | 1 | 95 | 1 |
| other | Atrial fibrillation | Cardiac disorders | MEDI3506 60 mg | 0 | 89 | 0 |
| other | Atrial fibrillation | Cardiac disorders | MEDI3506 120 mg | 1 | 93 | 1 |
| other | Atrial fibrillation | Cardiac disorders | MEDI3506 300 mg | 0 | 148 | 0 |
| other | Bacteriuria | Infections and infestations | Placebo | 0 | 133 | 0 |
| other | Bacteriuria | Infections and infestations | MEDI3506 30 mg | 0 | 95 | 0 |
| other | Bacteriuria | Infections and infestations | MEDI3506 60 mg | 0 | 89 | 0 |
| other | Bacteriuria | Infections and infestations | MEDI3506 120 mg | 0 | 93 | 0 |
| other | Bacteriuria | Infections and infestations | MEDI3506 300 mg | 1 | 148 | 1 |
1 to 10 of 1,580Source ClinicalTrials.gov
See all 1,580 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 1 | 133 |
| Total, all-cause mortality | MEDI3506 30 mg | 1 | 95 |
| Total, all-cause mortality | MEDI3506 60 mg | 1 | 89 |
| Total, all-cause mortality | MEDI3506 120 mg | 1 | 93 |
| Total, all-cause mortality | MEDI3506 300 mg | 1 | 148 |
| Total, other adverse events | Placebo | 62 | 133 |
| Total, other adverse events | MEDI3506 30 mg | 55 | 95 |
| Total, other adverse events | MEDI3506 60 mg | 39 | 89 |
| Total, other adverse events | MEDI3506 120 mg | 48 | 93 |
| Total, other adverse events | MEDI3506 300 mg | 74 | 148 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04170543
GET https://conductscience.org/api/trials/v1/NCT04170543/results?page=2