Trial · NCT00555217
VA NEPHRON-D: Diabetes iN Nephropathy Study
NCT00555217, Phase 3, Terminated, US Department of Veterans Affairs; results first posted 2015-05-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. VA NEPHRON-D: Diabetes iN Nephropathy Study. Trials, record NCT00555217. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00555217
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- VA NEPHRON-D: Diabetes iN Nephropathy Study
- NCT number
- NCT00555217
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 1,448 participants, actual
- Lead sponsor
- US Department of Veterans Affairs
- Conditions
- Kidney Disease, Nephropathy, Type 2 Diabetes
- Interventions
- losartan, lisinopril
- First posted
- 2007-11-08
- Last updated
- 2015-05-29
- Results first posted
- 2015-05-29
- Limitations and caveats
- In October, 2012 the DMC recommended that study treatment be stopped primarily because of safety concerns along with low conditional power to detect a treatment effect on the primary outcome.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | A Composite Endpoint of Reduction in Estimated GFR of 30ml/Min/1.73m*m in Individuals w/a Baseline Estimated GFR >= 60 ml/Min/1.73m*m, Reduction in Estimated GFR >50% in Individuals w/ Baseline Estimated GFR <60ml/Min/1.73m*m; ESRD or Death | From enrollemnt to time of first primary event, up to 4.5 years | Time to the first event of reduction in estimated GFR of 30ml/min/1.73m\*m in individuals w/a baseline estimated GFR \>= 60 ml/min/1.73m\*m, reduction in estimated GFR \>50% in individuals w/ baseline estimated GFR \<60ml/min/1.73m\*m; ESRD or death. |
| Secondary | A Renal Composite Endpoint, Defined as; Reduction in Estimated GFR of >50% (for Individuals With Baseline GFR <60) or Reduction in GFR of >30 (for Individuals With Baseline GFR >= GFR 60) or ESRD. | From enrollment to time of first event, up to 4.5 years | Time to the first event of reduction in estimated GFR of \>50% (for individuals with baseline GFR \<60) or reduction in GFR of \>30 (for individuals with baseline GFR \>= GFR 60) or ESRD. |
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 | A Composite Endpoint of Reduction in Estimated GFR of 30ml/Min/1.73m*m in Individuals w/a Baseline Estimated GFR >= 60 ml/Min/1.73m*m, Reduction in Estimated GFR >50% in Individuals w/ Baseline Estimated GFR <60ml/Min/1.73m*m; ESRD or Death | From enrollemnt to time of first primary event, up to 4.5 years | participants | NUMBER | |
| SECONDARY | A Renal Composite Endpoint, Defined as; Reduction in Estimated GFR of >50% (for Individuals With Baseline GFR <60) or Reduction in GFR of >30 (for Individuals With Baseline GFR >= GFR 60) or ESRD. | From enrollment to time of first event, up to 4.5 years | participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
A Composite Endpoint of Reduction in Estimated GFR of 30ml/Min/1.73m*m in Individuals w/a Baseline Estimated GFR >= 60 ml/Min/1.73m*m, Reduction in Estimated GFR >50% in Individuals w/ Baseline Estimated GFR <60ml/Min/1.73m*m; ESRD or Death | Combination of ARB and ACEI | 132 | participants | ||
A Composite Endpoint of Reduction in Estimated GFR of 30ml/Min/1.73m*m in Individuals w/a Baseline Estimated GFR >= 60 ml/Min/1.73m*m, Reduction in Estimated GFR >50% in Individuals w/ Baseline Estimated GFR <60ml/Min/1.73m*m; ESRD or Death | Monotherapy ARB | 152 | participants | ||
| A Renal Composite Endpoint, Defined as; Reduction in Estimated GFR of >50% (for Individuals With Baseline GFR <60) or Reduction in GFR of >30 (for Individuals With Baseline GFR >= GFR 60) or ESRD. | Combination of ARB and ACEI | 77 | participants | ||
| A Renal Composite Endpoint, Defined as; Reduction in Estimated GFR of >50% (for Individuals With Baseline GFR <60) or Reduction in GFR of >30 (for Individuals With Baseline GFR >= GFR 60) or ESRD. | Monotherapy ARB | 101 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Combination of ARB and ACEI | 724 | |
| Overall Study | STARTED | Monotherapy ARB | 724 | |
| Overall Study | COMPLETED | Combination of ARB and ACEI | 649 | |
| Overall Study | COMPLETED | Monotherapy ARB | 656 | |
| Overall Study | NOT COMPLETED | Combination of ARB and ACEI | 75 | |
| Overall Study | NOT COMPLETED | Monotherapy ARB | 68 |
Source ClinicalTrials.gov
Adverse events1,088
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 |
|---|---|---|---|---|---|---|
| serious | Anaemia of chronic disease | Blood and lymphatic system disorders | Combination of ARB and ACEI | 0 | 724 | 0 |
| serious | Anaemia of chronic disease | Blood and lymphatic system disorders | Monotherapy ARB | 1 | 724 | 2 |
| serious | Anaemia of malignant disease | Blood and lymphatic system disorders | Combination of ARB and ACEI | 1 | 724 | 1 |
| serious | Anaemia of malignant disease | Blood and lymphatic system disorders | Monotherapy ARB | 0 | 724 | 0 |
| serious | Anemia | Blood and lymphatic system disorders | Combination of ARB and ACEI | 15 | 724 | 23 |
| serious | Anemia | Blood and lymphatic system disorders | Monotherapy ARB | 12 | 724 | 13 |
| serious | Coagulopathy | Blood and lymphatic system disorders | Combination of ARB and ACEI | 1 | 724 | 1 |
| serious | Coagulopathy | Blood and lymphatic system disorders | Monotherapy ARB | 0 | 724 | 0 |
| serious | Idiopathic thrombocytopenic pu | Blood and lymphatic system disorders | Combination of ARB and ACEI | 0 | 724 | 0 |
| serious | Idiopathic thrombocytopenic pu | Blood and lymphatic system disorders | Monotherapy ARB | 1 | 724 | 3 |
1 to 10 of 1,088Source ClinicalTrials.gov
See all 1,088 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Combination of ARB and ACEI | ||
| Total, all-cause mortality | Monotherapy ARB | ||
| Total, other adverse events | Combination of ARB and ACEI | 0 | 724 |
| Total, other adverse events | Monotherapy ARB | 0 | 724 |
| Total, serious adverse events | Combination of ARB and ACEI | 416 | 724 |
| Total, serious adverse events | Monotherapy ARB | 380 | 724 |
Source ClinicalTrials.gov
Papers8
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Combination of ARB and ACEI vs Monotherapy ARB: A Composite Endpoint of Reduction in Estimated GFR of 30ml/Min/1.73m*m in Individuals w/a Baseline Estimated GFR >= 60 ml/Min/1.73m*m, Reduction in Estimated GFR >50% in Individuals w/ Baseline Estimated GFR <60ml/Min/1.73m*m; ESRD or Death | Trial comparisons |
Combination of ARB and ACEI vs Monotherapy ARB: A Renal Composite Endpoint, Defined as; Reduction in Estimated GFR of >50% (for Individuals With Baseline GFR <60) or Reduction in GFR of >30 (for Individuals With Baseline GFR >= GFR 60) or ESRD. | Trial comparisons |
| Combination of ARB and ACEI vs Monotherapy ARB: serious adverse events | Trial comparisons |
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/NCT00555217
GET https://conductscience.org/api/trials/v1/NCT00555217/events?page=2