Trial · NCT01885559

HALT Progression of Polycystic Kidney Disease Study B

NCT01885559, Phase 3, Completed, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); results first posted 2015-03-10

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ConductScience Library. HALT Progression of Polycystic Kidney Disease Study B. Trials, record NCT01885559. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01885559

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: HALT Progression of Polycystic Kidney Disease Study B
NCT number: NCT01885559
Status: Completed
Phases: Phase 3
Enrollment: 486 participants, actual
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions: Kidney, Polycystic
Interventions: Lisinopril, Telmisartan, Placebo
First posted: 2013-06-25
Last updated: 2020-04-22
Results first posted: 2015-03-10

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With 50% Reduction of Baseline eGFR, End Stage Renal Disease (ESRD, Initiation of Dialysis or Preemptive Transplant), or Death.	Patients followed for 5-8 years with average of 6.5 years follow up
Secondary	Albuminuria	up to 8 years (annually assessed)	Annual percent change in 24 hour urine albumin, centrally processed. Data from multiple years were analyzed with the primary focus on the change over time for the measure (from the slope of the model). The measure presented is the average annual percent change across the 8 years.
Secondary	Aldosterone	up at 8 years (annually assessed)	Annual percent change in urinary aldosterone, centrally processed measure. Data from multiple years were analyzed with the primary focus on the change over time for the measure (from the slope for time from the model). The measure presented is the average annual percent change across the 8 years.
Secondary	Hospitalizations	up to 8 years	Hospitalization for any cause
Secondary	Cardiovascular Hospitalizations	up to 8 years	Cause-specific hospitalizations (cardiovascular)
Secondary	Quality of Life Physical Component Summary	up to 8 years (annually assessed)	Short Form-36 Quality of Life Physical Component Summary ranges from 0 (worst possible outcome) to 100 (best possible outcome). Data from multiple years were analyzed with the primary focus on the change over time for the measure (from the slope for time from the model). The measure presented is the average annual change across the 8 years.
Secondary	Quality of Life Mental Component Summary	up to 8 years (annually assessed)	Short Form-36 Quality of Life Mental Component Summary ranges from 0 (worst possible outcome) to 100 (best possible outcome). Data from multiple years were analyzed with the primary focus on the change over time for the measure (from the slope for time from the model). The measure presented is the average annual change across the 8 years.
Secondary	Back or Flank Pain	48 months	Report of back or flank pain since the last visit (yes or no)

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With 50% Reduction of Baseline eGFR, End Stage Renal Disease (ESRD, Initiation of Dialysis or Preemptive Transplant), or Death.	Patients followed for 5-8 years with average of 6.5 years follow up	Intention to Treat analysis was used for the primary outcome	participants	NUMBER
SECONDARY	Albuminuria	up to 8 years (annually assessed)	Intention to treat analysis	annual percent change	MEAN
SECONDARY	Aldosterone	up at 8 years (annually assessed)	Intention to treat analyses	annual percent change	MEAN
SECONDARY	Hospitalizations	up to 8 years	Intention to treat analysis	events	NUMBER
SECONDARY	Cardiovascular Hospitalizations	up to 8 years	Intention to Treat analysis	events	NUMBER
SECONDARY	Quality of Life Physical Component Summary	up to 8 years (annually assessed)	Intention to Treat analysis	units on a scale per year	MEAN
SECONDARY	Quality of Life Mental Component Summary	up to 8 years (annually assessed)	Intention to treat analysis	units on a scale per year	MEAN
SECONDARY	Back or Flank Pain	48 months	Cross sectional analysis at 48 months is reported only for those participants responding at that time point. Intention to treat analysis was used for in the modeling over time to incorporate all repeated measures.	percentage of participants at 48 months	NUMBER

Source ClinicalTrials.gov

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Number of Participants With 50% Reduction of Baseline eGFR, End Stage Renal Disease (ESRD, Initiation of Dialysis or Preemptive Transplant), or Death.	ACE-I + Placebo	116		participants
Number of Participants With 50% Reduction of Baseline eGFR, End Stage Renal Disease (ESRD, Initiation of Dialysis or Preemptive Transplant), or Death.	ACE-I + ARB	115		participants
Albuminuria	ACE-I + Placebo	7.5	95% Confidence Interval 5.2 to 9.9	annual percent change
Albuminuria	ACE-I + ARB	7.3	95% Confidence Interval 4.9 to 9.7	annual percent change
Aldosterone	ACE-I + Placebo	-8.8	95% Confidence Interval -10.5 to -7.2	annual percent change
Aldosterone	ACE-I + ARB	-10.2	95% Confidence Interval -11.9 to -8.6	annual percent change
Hospitalizations	ACE-I + Placebo	173		events
Hospitalizations	ACE-I + ARB	136		events
Cardiovascular Hospitalizations	ACE-I + Placebo	29		events
Cardiovascular Hospitalizations	ACE-I + ARB	16		events

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	ACE-I + Placebo	242
Overall Study	STARTED	ACE-I + Angiotensin Receptor Blocker (ARB)	244
Overall Study	COMPLETED	ACE-I + Placebo	218
Overall Study	COMPLETED	ACE-I + Angiotensin Receptor Blocker (ARB)	208
Overall Study	NOT COMPLETED	ACE-I + Placebo	24
Overall Study	NOT COMPLETED	ACE-I + Angiotensin Receptor Blocker (ARB)	36

Source ClinicalTrials.gov

Adverse events222

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 + Placebo	32	242	51
other	Acute Kidney Injury	Renal and urinary disorders	ACE-I + ARB	22	244	31
other	Hyperkalemia	Metabolism and nutrition disorders	ACE-I + Placebo	41	242	65
other	Hyperkalemia	Metabolism and nutrition disorders	ACE-I + ARB	46	244	70
serious	Anemia	Blood and lymphatic system disorders	ACE-I + Placebo	0	242	0
serious	Anemia	Blood and lymphatic system disorders	ACE-I + ARB	2	244	2
serious	Blood and lymphatic system disorders - Other, specify	Blood and lymphatic system disorders	ACE-I + Placebo	0	242	0
serious	Blood and lymphatic system disorders - Other, specify	Blood and lymphatic system disorders	ACE-I + ARB	1	244	1
serious	Febrile neutropenia	Blood and lymphatic system disorders	ACE-I + Placebo	2	242	2
serious	Febrile neutropenia	Blood and lymphatic system disorders	ACE-I + ARB	0	244	0

1 to 10 of 222Source ClinicalTrials.gov

See all 222 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	ACE-I + Placebo
Total, all-cause mortality	ACE-I + ARB
Total, other adverse events	ACE-I + Placebo	66	242
Total, other adverse events	ACE-I + ARB	60	244
Total, serious adverse events	ACE-I + Placebo	88	242
Total, serious adverse events	ACE-I + ARB	88	244

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
25399731	DERIVED	PubMed
37250503	DERIVED	PubMed
39356039	DERIVED	PubMed

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 comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
ACE-I + Placebo vs ACE-I + ARB: Number of Participants With 50% Reduction of Baseline eGFR, End Stage Renal Disease (ESRD, Initiation of Dialysis or Preemptive Transplant), or Death.	Trial comparisons
ACE-I + Placebo vs ACE-I + 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01885559

GET https://conductscience.org/api/trials/v1/NCT01885559/events?page=2

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