Trial · NCT00283686
HALT Progression of Polycystic Kidney Disease Study A
NCT00283686, Phase 3, Completed, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); results first posted 2015-02-27
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. HALT Progression of Polycystic Kidney Disease Study A. Trials, record NCT00283686. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00283686
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- HALT Progression of Polycystic Kidney Disease Study A
- NCT number
- NCT00283686
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 558 participants, actual
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Conditions
- Kidney, Polycystic
- Interventions
- Lisinopril, Telmisartan, Placebo, Standard Blood Pressure Control, Low Blood Pressure Control
- First posted
- 2006-01-30
- Last updated
- 2020-04-21
- Results first posted
- 2015-02-27
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Study A: Percent Annual Change in Total Kidney Volume | Baseline and 2-, 4- and 5-year follow-up | Annual percentage change in total kidney volume as assessed by abdominal magnetic resonance imaging (MRI) at baseline, 2 years, 4 years, and 5 years follow-up. |
| Secondary | Kidney Function (eGFR) | Up to 96 months (6 month assessments) | The estimated GFR was calculated by means of the Chronic Kidney Disease Epidemiology Collaboration equation with the use of central serum creatinine measurements. |
| Secondary | Albuminuria | Up to 96 months (assessed annually) | Urine albumin excretion, centrally processed from 24 hour urine collection |
| Secondary | Aldosterone | Up to 96 months (assessed annually) | Urinary aldosterone excretion, centrally processed, 24 hour urine collection |
| Secondary | Left Ventricular Mass Index | 0, 24 months, 48 months, 60 months | Left ventricular mass index (g/m\^2) measured by MRI, centrally reviewed and measured |
| Secondary | Renal Blood Flow | 0, 24 months, 48 months, 60 months | renal blood flow (mL/min/1.73 m\^2) from MRI, centrally reviewed and measured. This outcome was more difficult to measure resulting in more missing data than other MRI outcomes such as total kidney volume (TKV) and left ventricular mass index (LVMI). |
| Secondary | All-Cause Hospitalizations | Up to 96 months | |
| Secondary | Quality of Life Physical Component Summary | baseline, 12, 24, 36, 48, 60, 72, 84, and 96 months (assessed annually) | Short Form-36 Quality of Life Physical Component Summary ranges from 0 (worst possible outcome) to 100 (best possible outcome) |
| Secondary | Quality of Life Mental Component Summary | baseline, 12, 24, 36, 48, 60, 72, 84, and 96 months (assessed annually) | Short Form-36 Quality of LIfe Mental Component Summary ranges from 0 (worst possible outcome) to 100 (best possible outcome) |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Study A: Percent Annual Change in Total Kidney Volume | Baseline and 2-, 4- and 5-year follow-up | Analyses were conducted on all participants who had at least one total kidney volume measurement using intention to treat. | percentage of Total Kidney Volume | MEAN |
| SECONDARY | Kidney Function (eGFR) | Up to 96 months (6 month assessments) | Analyses were intention to treat: All participants who were randomized. | ml/min/1.73/m2/yr | MEAN |
| SECONDARY | Albuminuria | Up to 96 months (assessed annually) | Analysis by intention to treat | annual percent change in mg/24 hr | MEAN |
| SECONDARY | Aldosterone | Up to 96 months (assessed annually) | Analysis using intention to treat | annual % change micrograms per 24 hr | MEAN |
| SECONDARY | Left Ventricular Mass Index | 0, 24 months, 48 months, 60 months | Analyses were conducted using intention to treat for participants with at least one left ventricular mass index measure. | annual change in g/m^2 | MEAN |
| SECONDARY | Renal Blood Flow | 0, 24 months, 48 months, 60 months | Analyses were conducted using intention to treat analyses for participants with at least one valid renal blood flow measure. | annual change in mL/min/1.73 m^2 | MEAN |
| SECONDARY | All-Cause Hospitalizations | Up to 96 months | Intention to treat analysis: All participants who were randomized. | events | NUMBER |
| SECONDARY | Quality of Life Physical Component Summary | baseline, 12, 24, 36, 48, 60, 72, 84, and 96 months (assessed annually) | Analysis using intention to treat | annual change in units on a scale | MEAN |
| SECONDARY | Quality of Life Mental Component Summary | baseline, 12, 24, 36, 48, 60, 72, 84, and 96 months (assessed annually) | Analysis using intention to treat. | annual change in units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Study A: Percent Annual Change in Total Kidney Volume | ACE-I + ARB | 6.0 | 95% Confidence Interval 5.5 to 6.4 | percentage of Total Kidney Volume | |
| Study A: Percent Annual Change in Total Kidney Volume | ACE-I Alone | 6.2 | 95% Confidence Interval 5.7 to 6.7 | percentage of Total Kidney Volume | |
| Study A: Percent Annual Change in Total Kidney Volume | Low Blood Pressure Group | 5.6 | 95% Confidence Interval 5.2 to 6.1 | percentage of Total Kidney Volume | |
| Study A: Percent Annual Change in Total Kidney Volume | Standard Blood Pressure Group | 6.6 | 95% Confidence Interval 6.1 to 7.1 | percentage of Total Kidney Volume | |
| Kidney Function (eGFR) | ACE-I + ARB | -3.0 | 95% Confidence Interval -3.3 to -2.7 | ml/min/1.73/m2/yr | |
| Kidney Function (eGFR) | ACE-I Alone | -2.9 | 95% Confidence Interval -3.2 to -2.6 | ml/min/1.73/m2/yr | |
| Kidney Function (eGFR) | Low Blood Pressure Group | -2.9 | 95% Confidence Interval -3.2 to -2.6 | ml/min/1.73/m2/yr | |
| Kidney Function (eGFR) | Standard Blood Pressure Group | -3.0 | 95% Confidence Interval -3.3 to -2.7 | ml/min/1.73/m2/yr | |
| Albuminuria | ACE-I + ARB | -1.1 | 95% Confidence Interval -3.1 to 0.8 | annual percent change in mg/24 hr | |
| Albuminuria | ACE-I Alone | -0.4 | 95% Confidence Interval -2.3 to 1.6 | annual percent change in mg/24 hr |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ACE-I/ARB and Standard BP | 140 | |
| Overall Study | STARTED | ACE-I/ARB and Low BP | 133 | |
| Overall Study | STARTED | ACE-I/Placebo and Standard BP | 144 | |
| Overall Study | STARTED | ACE-I/Placebo and Low BP | 141 | |
| Overall Study | COMPLETED | ACE-I/ARB and Standard BP | 111 | |
| Overall Study | COMPLETED | ACE-I/ARB and Low BP | 92 | |
| Overall Study | COMPLETED | ACE-I/Placebo and Standard BP | 111 | |
| Overall Study | COMPLETED | ACE-I/Placebo and Low BP | 109 | |
| Overall Study | NOT COMPLETED | ACE-I/ARB and Standard BP | 29 | |
| Overall Study | NOT COMPLETED | ACE-I/ARB and Low BP | 41 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events396
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 | Acute kidney injury | Renal and urinary disorders | ACE-I + ARB | 13 | 273 | 15 |
| other | Acute kidney injury | Renal and urinary disorders | ACE-I Alone | 16 | 285 | 19 |
| other | Acute kidney injury | Renal and urinary disorders | Low Blood Pressure Group | 16 | 274 | 17 |
| other | Acute kidney injury | Renal and urinary disorders | Standard Blood Pressure Group | 13 | 284 | 17 |
| other | Hyperkalemia | Metabolism and nutrition disorders | ACE-I + ARB | 11 | 273 | 13 |
| other | Hyperkalemia | Metabolism and nutrition disorders | ACE-I Alone | 5 | 285 | 6 |
| other | Hyperkalemia | Metabolism and nutrition disorders | Low Blood Pressure Group | 7 | 274 | 8 |
| other | Hyperkalemia | Metabolism and nutrition disorders | Standard Blood Pressure Group | 9 | 284 | 11 |
| serious | Anemia | Blood and lymphatic system disorders | ACE-I + ARB | 1 | 273 | 1 |
| serious | Anemia | Blood and lymphatic system disorders | ACE-I Alone | 0 | 285 | 0 |
1 to 10 of 396Source ClinicalTrials.gov
See all 396 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ACE-I + ARB | ||
| Total, all-cause mortality | ACE-I Alone | ||
| Total, all-cause mortality | Low Blood Pressure Group | ||
| Total, all-cause mortality | Standard Blood Pressure Group | ||
| Total, other adverse events | ACE-I + ARB | 23 | 273 |
| Total, other adverse events | ACE-I Alone | 21 | 285 |
| Total, other adverse events | Low Blood Pressure Group | 23 | 274 |
| Total, other adverse events | Standard Blood Pressure Group | 21 | 284 |
| Total, serious adverse events | ACE-I + ARB | 58 | 273 |
| Total, serious adverse events | ACE-I Alone | 90 | 285 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers7
The papers the trial lists on ClinicalTrials.gov.
Grants2
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U01DK082230 | Data Coordinating Center for the Halt-Polycystic Kidney Disease Trials | ABEBE, KALEAB Z | UNIVERSITY OF PITTSBURGH AT PITTSBURGH | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2008 to 2014 | NIH RePORTER |
| U01DK062401 | Data Coordinating Center for PKD Treatment Network | MILLER, J. PHILIP | WASHINGTON UNIVERSITY | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2002 to 2008 | NIH RePORTER |
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/NCT00283686
GET https://conductscience.org/api/trials/v1/NCT00283686/results?page=2