Trial · NCT03217591
A Study to Evaluate the Soluble Guanylate Cyclase (sGC) Stimulator IW-1973 in Diabetic Nephropathy / Diabetic Kidney Disease as Measured by Albuminuria
NCT03217591, Phase 2, Completed, Akebia Therapeutics; results first posted 2022-09-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate the Soluble Guanylate Cyclase (sGC) Stimulator IW-1973 in Diabetic Nephropathy / Diabetic Kidney Disease as Measured by Albuminuria. Trials, record NCT03217591. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03217591
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Soluble Guanylate Cyclase (sGC) Stimulator IW-1973 in Diabetic Nephropathy / Diabetic Kidney Disease as Measured by Albuminuria
- NCT number
- NCT03217591
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 156 participants, actual
- Lead sponsor
- Akebia Therapeutics
- Conditions
- Type 2 Diabetes Mellitus With Diabetic Nephropathy
- Interventions
- IW-1973, IW-1973, Placebo
- First posted
- 2017-07-14
- Last updated
- 2022-09-15
- Results first posted
- 2022-09-15
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs) and Study Drug-Related TEAEs | Day 1 up to Day 115 | An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. TEAEs are defined as those AEs that started or worsened in severity after the initiation of study drug administration. Causality relationship to study drug was per Investigator assessment. |
| Primary | Percent Change From Baseline in Urine Albumin Creatinine Ratio (UACR) Over Weeks 8 and 12 | Baseline; Week 8 to Week 12 | Urine samples were collected for the analysis of UACR. UACR (milligrams per gram \[mg/g\]) was calculated as urine albumin (mg per deciliter \[mg/dL\]) / urine creatinine (g/dL). Change from Baseline was calculated as the average of the UCAR values at Weeks 8 and 12 minus the Baseline value. Data were analyzed using a mixed-effects model repeated measures (MMRM) analysis with change from Baseline in log-transformed UACR as the response variable, treatment, visit, treatment-by visit interaction, and Baseline estimated glomerular filtration rate stratum as fixed effects, Baseline log-transformed UACR and Baseline mean arterial pressure as covariates, and unstructured as the variance-covariance structure. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs) and Study Drug-Related TEAEs | Day 1 up to Day 115 | Safety Population consisted of all randomized participants who received at least 1 dose of study drug. Participants in this population were summarized according to the treatment they actually received. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Percent Change From Baseline in Urine Albumin Creatinine Ratio (UACR) Over Weeks 8 and 12 | Baseline; Week 8 to Week 12 | Intent-to-Treat Population consisted of all randomized participants who received at least 1 dose of study drug. Participants in this population were evaluated according to the treatment group they were assigned to at Randomization. | Percent Change | GEOMETRIC_LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs) and Study Drug-Related TEAEs | Placebo | Any TEAE | 24 | Participants | |
| Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs) and Study Drug-Related TEAEs | Praliciguat 20 mg | Any TEAE | 21 | Participants | |
| Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs) and Study Drug-Related TEAEs | Praliciguat 40 mg | Any TEAE | 22 | Participants | |
| Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs) and Study Drug-Related TEAEs | Placebo | Study drug-related TEAEs | 6 | Participants | |
| Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs) and Study Drug-Related TEAEs | Praliciguat 20 mg | Study drug-related TEAEs | 3 | Participants | |
| Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs) and Study Drug-Related TEAEs | Praliciguat 40 mg | Study drug-related TEAEs | 10 | Participants | |
| Percent Change From Baseline in Urine Albumin Creatinine Ratio (UACR) Over Weeks 8 and 12 | Placebo | -14.8 | 90% Confidence Interval -27.7 to 0.4 | Percent Change | |
| Percent Change From Baseline in Urine Albumin Creatinine Ratio (UACR) Over Weeks 8 and 12 | Praliciguat 20 mg | -28.4 | 90% Confidence Interval -39.4 to -15.3 | Percent Change | |
| Percent Change From Baseline in Urine Albumin Creatinine Ratio (UACR) Over Weeks 8 and 12 | Praliciguat 40 mg | -27.3 | 90% Confidence Interval -39.2 to -13.1 | Percent Change | |
| Percent Change From Baseline in Urine Albumin Creatinine Ratio (UACR) Over Weeks 8 and 12 | Praliciguat Overall | -27.8 | 90% Confidence Interval -36.3 to -18.3 | Percent Change |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 54 | |
| Overall Study | STARTED | Praliciguat 20 mg | 50 | |
| Overall Study | STARTED | Praliciguat 40 mg | 52 | |
| Overall Study | COMPLETED | Placebo | 51 | |
| Overall Study | COMPLETED | Praliciguat 20 mg | 47 | |
| Overall Study | COMPLETED | Praliciguat 40 mg | 42 | |
| Overall Study | NOT COMPLETED | Placebo | 3 | |
| Overall Study | NOT COMPLETED | Praliciguat 20 mg | 3 | |
| Overall Study | NOT COMPLETED | Praliciguat 40 mg | 10 |
Source ClinicalTrials.gov
Adverse events303
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 | Anaemia | Blood and lymphatic system disorders | Placebo | 1 | 54 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Praliciguat 20 mg | 0 | 50 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Praliciguat 40 mg | 0 | 52 | 0 |
| other | Atrial fibrillation | Cardiac disorders | Placebo | 0 | 54 | 0 |
| other | Atrial fibrillation | Cardiac disorders | Praliciguat 20 mg | 0 | 50 | 0 |
| other | Atrial fibrillation | Cardiac disorders | Praliciguat 40 mg | 1 | 52 | 1 |
| other | Palpitations | Cardiac disorders | Placebo | 0 | 54 | 0 |
| other | Palpitations | Cardiac disorders | Praliciguat 20 mg | 0 | 50 | 0 |
| other | Palpitations | Cardiac disorders | Praliciguat 40 mg | 1 | 52 | 1 |
| other | Tachycardia | Cardiac disorders | Placebo | 0 | 54 | 0 |
1 to 10 of 303Source ClinicalTrials.gov
See all 303 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 54 |
| Total, all-cause mortality | Praliciguat 20 mg | 0 | 50 |
| Total, all-cause mortality | Praliciguat 40 mg | 0 | 52 |
| Total, other adverse events | Placebo | 24 | 54 |
| Total, other adverse events | Praliciguat 20 mg | 21 | 50 |
| Total, other adverse events | Praliciguat 40 mg | 21 | 52 |
| Total, serious adverse events | Placebo | 1 | 54 |
| Total, serious adverse events | Praliciguat 20 mg | 1 | 50 |
| Total, serious adverse events | Praliciguat 40 mg | 4 | 52 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33328269 | DERIVED |
Source PubMed
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/NCT03217591
GET https://conductscience.org/api/trials/v1/NCT03217591/events?page=2