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Trial record 2 of 3 for:    "Polycystic Kidney Disease" | "Calcium"

HALT Progression of Polycystic Kidney Disease (HALT PKD) Study A

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ClinicalTrials.gov Identifier: NCT00283686
Recruitment Status : Completed
First Posted : January 30, 2006
Results First Posted : February 27, 2015
Last Update Posted : March 19, 2015
Sponsor:
Collaborators:
Boehringer Ingelheim
Merck Sharp & Dohme Corp.
Polycystic Kidney Disease Foundation
Information provided by (Responsible Party):
Charity G Moore, PhD, University of Pittsburgh

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Kidney, Polycystic
Interventions Drug: Lisinopril
Drug: Telmisartan
Drug: Placebo
Other: Standard Blood Pressure Control
Other: Low Blood Pressure Control
Enrollment 558
Recruitment Details Participants were enrolled at seven clinical sites between February 2006 and June 2009.
Pre-assignment Details  
Arm/Group Title ACE-I/ARB and Standard BP ACE-I/ARB and Low BP ACE-I/Placebo and Standard BP ACE-I/Placebo and Low BP
Hide Arm/Group Description

ACE-I + angiotensin-receptor blocker (ARB) and standard blood pressure control of 120-130/70-80 mm Hg

Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 120-130/70-80 mm Hg.

ACE-I + angiotensin-receptor blocker (ARB) and low blood pressure control of 95-110/60-75 mm Hg

Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve low blood pressure control of 95-110/60-75 mm Hg.

ACE-I + Placebo and standard blood pressure control of 120-130/70-80 mm Hg

Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 120-130/70-80 mm Hg.

ACE-I + Placebo and low blood pressure control of 95-110/60-75 mm Hg

Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve low blood pressure control of 95-110/60-75 mm Hg.

Period Title: Overall Study
Started 140 133 144 141
Completed 111 92 111 109
Not Completed 29 41 33 32
Reason Not Completed
Death             1             1             1             0
Lost to Follow-up             21             31             26             20
Less than full participation             7             9             6             12
Arm/Group Title ACE-I/ARB and Standard BP ACE-I/ARB and Low BP ACE-I/Placebo and Standard BP ACE-I/Placebo and Low BP Total
Hide Arm/Group Description

ACE-I + ARB and standard blood pressure control of 120-130/70-80 mm Hg

Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 120-130/70-80 mm Hg.

ACE-I + ARB and low blood pressure control of 95-110/60-75 mm Hg

Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve low blood pressure control of 95-110/60-75 mm Hg.

ACE-I + Placebo and standard blood pressure control of 120-130/70-80 mm Hg

Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 120-130/70-80 mm Hg.

ACE-I + Placebo and low blood pressure control of 95-110/60-75 mm Hg

Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve low blood pressure control of 95-110/60-75 mm Hg.

Total of all reporting groups
Overall Number of Baseline Participants 140 133 144 141 558
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 140 participants 133 participants 144 participants 141 participants 558 participants
37.0  (8.3) 37.1  (8.4) 35.8  (8.6) 36.8  (8.0) 36.7  (8.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 140 participants 133 participants 144 participants 141 participants 558 participants
Female
68
  48.6%
64
  48.1%
73
  50.7%
70
  49.6%
275
  49.3%
Male
72
  51.4%
69
  51.9%
71
  49.3%
71
  50.4%
283
  50.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 140 participants 133 participants 144 participants 141 participants 558 participants
American Indian or Alaska Native
1
   0.7%
0
   0.0%
2
   1.4%
2
   1.4%
5
   0.9%
Asian
1
   0.7%
1
   0.8%
2
   1.4%
1
   0.7%
5
   0.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
   2.9%
2
   1.5%
3
   2.1%
5
   3.5%
14
   2.5%
White
127
  90.7%
128
  96.2%
131
  91.0%
131
  92.9%
517
  92.7%
More than one race
5
   3.6%
2
   1.5%
6
   4.2%
2
   1.4%
15
   2.7%
Unknown or Not Reported
2
   1.4%
0
   0.0%
0
   0.0%
0
   0.0%
2
   0.4%
Age at Diagnosis of autosomal dominant polycystic kidney disease (ADPKD)  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 140 participants 133 participants 144 participants 141 participants 558 participants
27.2  (10.0) 28.5  (10.0) 27.0  (9.5) 27.6  (10.4) 27.6  (10.0)
Body Mass Index (kg/m2)  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 140 participants 133 participants 144 participants 141 participants 558 participants
27.4  (5.4) 27.4  (5.1) 27.3  (5.5) 26.8  (4.8) 27.2  (5.2)
Serum Creatinine (mg/dl)  
Mean (Standard Deviation)
Unit of measure:  Mg/dl
Number Analyzed 140 participants 133 participants 144 participants 141 participants 558 participants
1.0  (0.3) 1.0  (0.2) 0.9  (0.2) 1.0  (0.2) 1.0  (0.2)
Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) eGFR (ml/min/m2)  
Mean (Standard Deviation)
Unit of measure:  Ml/min/m2
Number Analyzed 140 participants 133 participants 144 participants 141 participants 558 participants
88.5  (18.8) 86.5  (19.3) 92.9  (18.5) 87.6  (17.2) 88.9  (18.5)
PKD Genotype  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 140 participants 133 participants 144 participants 141 participants 558 participants
PKD1 103 87 101 91 382
PKD2 15 27 19 23 84
No Mutation Detected 10 10 12 14 46
No information 12 9 12 13 46
1.Primary Outcome
Title Study A: Percent Annual Change in Total Kidney Volume
Hide Description 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.
Time Frame Baseline and 2-, 4- and 5-year follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses were conducted on all participants who had at least one total kidney volume measurement using intention to treat.
Arm/Group Title ACE-I + ARB ACE-I Alone Low Blood Pressure Group Standard Blood Pressure Group
Hide Arm/Group Description:
ACE-I plus ARB (Lisinopril plus telmisartan)
ACE-I monotherapy (lisinopril only)
Targeted blood pressure was 95/60 to 110/75 mm Hg
Targeted blood pressure was 120/70 to 130/80 mm Hg
Overall Number of Participants Analyzed 271 282 271 282
Mean (95% Confidence Interval)
Unit of Measure: percentage of Total Kidney Volume
6.0
(5.5 to 6.4)
6.2
(5.7 to 6.7)
5.6
(5.2 to 6.1)
6.6
(6.1 to 7.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ACE-I + ARB, ACE-I Alone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.52
Comments adjusted for age, sex, race, baseline estimated GFR, and clinical site.
Method Mixed Models Analysis
Comments Test for differences between treatment groups over time.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-0.8 to 5.0
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Low Blood Pressure Group, Standard Blood Pressure Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments adjusted for age, sex, race, baseline estimated GFR, and clinical site.
Method Mixed Models Analysis
Comments Testing differences between blood pressure groups over time
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.0
Confidence Interval (2-Sided) 95%
-1.6 to -0.2
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Kidney Function (eGFR)
Hide Description The estimated GFR was calculated by means of the Chronic Kidney Disease Epidemiology Collaboration equation with the use of central serum creatinine measurements.
Time Frame Up to 96 months (6 month assessments)
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses were intention to treat: All participants who were randomized.
Arm/Group Title ACE-I + ARB ACE-I Alone Low Blood Pressure Group Standard Blood Pressure Group
Hide Arm/Group Description:
ACE-I plus ARB (Lisinopril plus telmisartan)
ACE-I monotherapy (lisinopril only)
Targeted blood pressure was 95/60 to 110/75 mm Hg
Targeted blood pressure was 120/70 to 130/80 mm Hg
Overall Number of Participants Analyzed 273 284 274 283
Mean (95% Confidence Interval)
Unit of Measure: ml/min/1.73/m2/yr
-3.0
(-3.3 to -2.7)
-2.9
(-3.2 to -2.6)
-2.9
(-3.2 to -2.6)
-3.0
(-3.3 to -2.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ACE-I + ARB, ACE-I Alone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.52
Comments adjusting for age, sex, race, and clinical site
Method Mixed Models Analysis
Comments Testing for differences in treatment over time (differences in slopes over time).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.6 to 0.3
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Low Blood Pressure Group, Standard Blood Pressure Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.55
Comments adjusted for age, sex, race, and clinical site
Method Mixed Models Analysis
Comments Testing for differences between groups over time (differences in slopes over time)
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.3 to 0.6
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Albuminuria
Hide Description Urine albumin excretion, centrally processed from 24 hour urine collection
Time Frame Up to 96 months (assessed annually)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis by intention to treat
Arm/Group Title ACE-I + ARB ACE-I Alone Low Blood Pressure Group Standard Blood Pressure Group
Hide Arm/Group Description:
ACE-I plus ARB (Lisinopril plus telmisartan)
ACE-I monotherapy (lisinopril only)
Targeted blood pressure was 95/60 to 110/75 mm Hg
Targeted blood pressure was 120/70 to 130/80 mm Hg
Overall Number of Participants Analyzed 273 284 274 283
Mean (95% Confidence Interval)
Unit of Measure: annual percent change in mg/24 hr
-1.1
(-3.1 to 0.8)
-0.4
(-2.3 to 1.6)
-3.8
(-5.7 to -1.8)
2.4
(0.5 to 4.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ACE-I + ARB, ACE-I Alone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.57
Comments [Not Specified]
Method Mixed Models Analysis
Comments adjusting for age, sex, race, and clinical site
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.7
Confidence Interval (2-Sided) 95%
-3.3 to 1.9
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Low Blood Pressure Group, Standard Blood Pressure Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments adjusting for age, sex, race, and clinical site
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.1
Confidence Interval (2-Sided) 95%
-8.5 to -3.4
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Aldosterone
Hide Description Urinary aldosterone excretion, centrally processed, 24 hour urine collection
Time Frame Up to 96 months (assessed annually)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis using intention to treat
Arm/Group Title ACE-I + ARB ACE-I Alone Low Blood Pressure Group Standard Blood Pressure Group
Hide Arm/Group Description:
ACE-I plus ARB (Lisinopril plus telmisartan)
ACE-I monotherapy (lisinopril only)
Targeted blood pressure was 95/60 to 110/75 mm Hg
Targeted blood pressure was 120/70 to 130/80 mm Hg
Overall Number of Participants Analyzed 273 284 274 283
Mean (95% Confidence Interval)
Unit of Measure: annual % change micrograms per 24 hr
-8.5
(-9.9 to -7.2)
-7.3
(-8.7 to -5.9)
-8.5
(-9.9 to -7.1)
-7.3
(-8.6 to -5.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ACE-I + ARB, ACE-I Alone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.18
Comments [Not Specified]
Method Mixed Models Analysis
Comments adjusting for age, sex, race, and clinical site
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.3
Confidence Interval (2-Sided) 95%
-3.1 to 0.6
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Low Blood Pressure Group, Standard Blood Pressure Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.19
Comments [Not Specified]
Method Mixed Models Analysis
Comments adjusting for age, sex, race, and clinical site
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.2
Confidence Interval (2-Sided) 95%
-3.1 to 0.6
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Left Ventricular Mass Index
Hide Description Left ventricular mass index (g/m^2) measured by MRI, centrally reviewed and measured
Time Frame 0, 24 months, 48 months, 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses were conducted using intention to treat for participants with at least one left ventricular mass index measure.
Arm/Group Title ACE-I + ARB ACE-I Alone Low Blood Pressure Group Standard Blood Pressure Group
Hide Arm/Group Description:
ACE-I plus ARB (Lisinopril plus telmisartan)
ACE-I monotherapy (lisinopril only)
Targeted blood pressure was 95/60 to 110/75 mm Hg
Targeted blood pressure was 120/70 to 130/80 mm Hg
Overall Number of Participants Analyzed 268 274 265 277
Mean (95% Confidence Interval)
Unit of Measure: annual change in g/m^2
-0.91
(-1.15 to -0.68)
-0.83
(-1.06 to -0.59)
-1.17
(-1.41 to -0.93)
-0.57
(-0.80 to -0.34)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ACE-I + ARB, ACE-I Alone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.58
Comments [Not Specified]
Method Mixed Models Analysis
Comments adjusted for age, sex, race, baseline estimated GFR, and clinical site
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.088
Confidence Interval (2-Sided) 95%
-0.40 to 0.22
Estimation Comments comparing the annual change over time between ACE/ARB and ACE alone
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Low Blood Pressure Group, Standard Blood Pressure Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Mixed Models Analysis
Comments adjusted for age, sex, race, baseline estimated GFR, and clinical site
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.60
Confidence Interval (2-Sided) 95%
-0.91 to -0.29
Estimation Comments comparing annual change in LVMI between Low Blood Pressure and Standard Blood Pressure groups
6.Secondary Outcome
Title Renal Blood Flow
Hide Description 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).
Time Frame 0, 24 months, 48 months, 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses were conducted using intention to treat analyses for participants with at least one valid renal blood flow measure.
Arm/Group Title ACE-I + ARB ACE-I Alone Low Blood Pressure Group Standard Blood Pressure Group
Hide Arm/Group Description:
ACE-I plus ARB (Lisinopril plus telmisartan)
ACE-I monotherapy (lisinopril only)
Targeted blood pressure was 95/60 to 110/75 mm Hg
Targeted blood pressure was 120/70 to 130/80 mm Hg
Overall Number of Participants Analyzed 233 247 236 244
Mean (95% Confidence Interval)
Unit of Measure: annual change in mL/min/1.73 m^2
-6.6
(-11.0 to -2.1)
-9.5
(-14.0 to -5.1)
-7.6
(-12.0 to -3.1)
-8.5
(-13.0 to -4.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ACE-I + ARB, ACE-I Alone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.29
Comments [Not Specified]
Method Mixed Models Analysis
Comments adjusted for age, sex, race, baseline estimated GFR, and clinical site
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.97
Confidence Interval (2-Sided) 95%
-2.55 to 8.50
Estimation Comments difference in annual change in mL/min/1.73 m^2 for ACE+ARB compared to ACE alone
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Low Blood Pressure Group, Standard Blood Pressure Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.73
Comments [Not Specified]
Method Mixed Models Analysis
Comments adjusting for age, sex, race, baseline estimated GFR, and clinical site
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
-4.54 to 6.50
Estimation Comments difference in annual change mL/min/1.73 m^2 between low and standard blood pressure groups
7.Secondary Outcome
Title All-Cause Hospitalizations
Hide Description [Not Specified]
Time Frame Up to 96 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat analysis: All participants who were randomized.
Arm/Group Title ACE-I + ARB ACE-I Alone Low Blood Pressure Group Standard Blood Pressure Group
Hide Arm/Group Description:
ACE-I plus ARB (Lisinopril plus telmisartan)
ACE-I monotherapy (lisinopril only)
Targeted blood pressure was 95/60 to 110/75 mm Hg
Targeted blood pressure was 120/70 to 130/80 mm Hg
Overall Number of Participants Analyzed 273 285 274 284
Measure Type: Number
Unit of Measure: events
85 128 93 120
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ACE-I + ARB, ACE-I Alone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0228
Comments [Not Specified]
Method Regression, Cox
Comments adjusting for age, sex, race, and clinical site
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.71
Confidence Interval (2-Sided) 95%
0.53 to 0.95
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Low Blood Pressure Group, Standard Blood Pressure Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.59
Comments [Not Specified]
Method Regression, Cox
Comments adjusting for age, sex, race, and clinical site
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.93
Confidence Interval (2-Sided) 95%
0.70 to 1.22
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Quality of Life Physical Component Summary
Hide Description Short Form-36 Quality of Life Physical Component Summary ranges from 0 (worst possible outcome) to 100 (best possible outcome)
Time Frame baseline, 12, 24, 36, 48, 60, 72, 84, and 96 months (assessed annually)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis using intention to treat
Arm/Group Title ACE-I + ARB ACE-I Alone Low Blood Pressure Group Standard Blood Pressure Group
Hide Arm/Group Description:
ACE-I plus ARB (Lisinopril plus telmisartan)
ACE-I monotherapy (lisinopril only)
Targeted blood pressure was 95/60 to 110/75 mm Hg
Targeted blood pressure was 120/70 to 130/80 mm Hg
Overall Number of Participants Analyzed 273 285 274 284
Mean (95% Confidence Interval)
Unit of Measure: annual change in units on a scale
-0.24
(-0.37 to -0.11)
-.23
(-.35 to -0.10)
-0.17
(-0.30 to -0.03)
-0.30
(-0.43 to -0.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ACE-I + ARB, ACE-I Alone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.87
Comments [Not Specified]
Method Mixed Models Analysis
Comments adjusting for age, sex, race, and clinical site
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.016
Confidence Interval (2-Sided) 95%
-0.19 to 0.17
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Low Blood Pressure Group, Standard Blood Pressure Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.14
Comments [Not Specified]
Method Mixed Models Analysis
Comments adjusting for age, sex, race, and clinical site
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.13
Confidence Interval (2-Sided) 95%
-0.046 to 0.31
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Quality of Life Mental Component Summary
Hide Description Short Form-36 Quality of LIfe Mental Component Summary ranges from 0 (worst possible outcome) to 100 (best possible outcome)
Time Frame baseline, 12, 24, 36, 48, 60, 72, 84, and 96 months (assessed annually)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis using intention to treat.
Arm/Group Title ACE-I + ARB ACE-I Alone Low Blood Pressure Group Standard Blood Pressure Group
Hide Arm/Group Description:
ACE-I plus ARB (Lisinopril plus telmisartan)
ACE-I monotherapy (lisinopril only)
Targeted blood pressure was 95/60 to 110/75 mm Hg
Targeted blood pressure was 120/70 to 130/80 mm Hg
Overall Number of Participants Analyzed 273 285 274 284
Mean (95% Confidence Interval)
Unit of Measure: annual change in units on a scale
0.19
(0.03 to 0.35)
-0.06
(-0.21 to 0.10)
-0.05
(-0.21 to 0.11)
0.18
(0.03 to 0.33)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ACE-I + ARB, ACE-I Alone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0221
Comments [Not Specified]
Method Mixed Models Analysis
Comments adjusting for age, sex, race, and clinical site
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.25
Confidence Interval (2-Sided) 95%
0.036 to 0.46
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Low Blood Pressure Group, Standard Blood Pressure Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0339
Comments [Not Specified]
Method Mixed Models Analysis
Comments adjusting for age, sex, race, and clinical site
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.23
Confidence Interval (2-Sided) 95%
-0.44 to -0.018
Estimation Comments [Not Specified]
Time Frame 5-8 years with average follow-up of 5.7 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ACE-I + ARB ACE-I Alone Low Blood Pressure Group Standard Blood Pressure Group
Hide Arm/Group Description ACE-I plus ARB (Lisinopril plus telmisartan) ACE-I monotherapy (lisinopril only) Targeted blood pressure was 95/60 to 110/75 mm Hg Targeted blood pressure was 120/70 to 130/80 mm Hg
All-Cause Mortality
ACE-I + ARB ACE-I Alone Low Blood Pressure Group Standard Blood Pressure Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
ACE-I + ARB ACE-I Alone Low Blood Pressure Group Standard Blood Pressure Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   58/273 (21.25%)      90/285 (31.58%)      69/274 (25.18%)      79/284 (27.82%)    
Blood and lymphatic system disorders         
Anemia  1  1/273 (0.37%)  1 0/285 (0.00%)  0 0/274 (0.00%)  0 1/284 (0.35%)  1
Cardiac disorders         
Atrial fibrillation  1  1/273 (0.37%)  3 3/285 (1.05%)  4 1/274 (0.36%)  1 3/284 (1.06%)  6
Atrial flutter  1  1/273 (0.37%)  1 0/285 (0.00%)  0 0/274 (0.00%)  0 1/284 (0.35%)  1
Cardiac arrest  1  0/273 (0.00%)  0 1/285 (0.35%)  1 0/274 (0.00%)  0 1/284 (0.35%)  1
Chest pain - cardiac  1  2/273 (0.73%)  2 0/285 (0.00%)  0 0/274 (0.00%)  0 2/284 (0.70%)  2
Myocardial infarction  1  0/273 (0.00%)  0 1/285 (0.35%)  1 1/274 (0.36%)  1 0/284 (0.00%)  0
Palpitations  1  1/273 (0.37%)  1 0/285 (0.00%)  0 1/274 (0.36%)  1 0/284 (0.00%)  0
Aortic valve disease  1  2/273 (0.73%)  2 0/285 (0.00%)  0 0/274 (0.00%)  0 2/284 (0.70%)  2
Gastrointestinal disorders         
Abdominal pain  1  3/273 (1.10%)  3 6/285 (2.11%)  9 3/274 (1.09%)  5 6/284 (2.11%)  7
Colitis  1  1/273 (0.37%)  1 0/285 (0.00%)  0 0/274 (0.00%)  0 1/284 (0.35%)  1
Diarrhea  1  0/273 (0.00%)  0 3/285 (1.05%)  3 1/274 (0.36%)  1 2/284 (0.70%)  2
Gastritis  1  1/273 (0.37%)  1 0/285 (0.00%)  0 1/274 (0.36%)  1 0/284 (0.00%)  0
Gastrointestinal disorders - Other, specify  1  0/273 (0.00%)  0 3/285 (1.05%)  3 0/274 (0.00%)  0 3/284 (1.06%)  3
Hemorrhoids  1  0/273 (0.00%)  0 1/285 (0.35%)  1 0/274 (0.00%)  0 1/284 (0.35%)  1
Pancreatitis  1  1/273 (0.37%)  2 0/285 (0.00%)  0 0/274 (0.00%)  0 1/284 (0.35%)  2
Small intestinal obstruction  1  1/273 (0.37%)  1 0/285 (0.00%)  0 0/274 (0.00%)  0 1/284 (0.35%)  1
Vomiting  1  1/273 (0.37%)  2 0/285 (0.00%)  0 0/274 (0.00%)  0 1/284 (0.35%)  2
Lower gastrointestinal hemorrhage  1  0/273 (0.00%)  0 1/285 (0.35%)  1 0/274 (0.00%)  0 1/284 (0.35%)  1
Ileal obstruction  1  1/273 (0.37%)  1 0/285 (0.00%)  0 0/274 (0.00%)  0 1/284 (0.35%)  1
General disorders         
Death NOS  1  1/273 (0.37%)  1 0/285 (0.00%)  0 0/274 (0.00%)  0 1/284 (0.35%)  1
Fever  1  1/273 (0.37%)  1 2/285 (0.70%)  2 2/274 (0.73%)  2 1/284 (0.35%)  1
Pain  1  2/273 (0.73%)  3 0/285 (0.00%)  0 1/274 (0.36%)  1 1/284 (0.35%)  2
Edema limbs  1  0/273 (0.00%)  0 1/285 (0.35%)  1 0/274 (0.00%)  0 1/284 (0.35%)  1
Hepatobiliary disorders         
Cholecystitis  1  2/273 (0.73%)  2 1/285 (0.35%)  1 2/274 (0.73%)  2 1/284 (0.35%)  1
Gallbladder obstruction  1  0/273 (0.00%)  0 1/285 (0.35%)  1 1/274 (0.36%)  1 0/284 (0.00%)  0
Hepatobiliary disorders - Other, specify  1  0/273 (0.00%)  0 5/285 (1.75%)  5 2/274 (0.73%)  2 3/284 (1.06%)  3
Infections and infestations         
Appendicitis  1  1/273 (0.37%)  1 2/285 (0.70%)  2 2/274 (0.73%)  2 1/284 (0.35%)  1
Appendicitis perforated  1  1/273 (0.37%)  1 0/285 (0.00%)  0 1/274 (0.36%)  1 0/284 (0.00%)  0
Hepatitis viral  1  0/273 (0.00%)  0 1/285 (0.35%)  2 0/274 (0.00%)  0 1/284 (0.35%)  2
Infections and infestations - Other, specify  1  1/273 (0.37%)  1 0/285 (0.00%)  0 1/274 (0.36%)  1 0/284 (0.00%)  0
Joint infection  1  0/273 (0.00%)  0 1/285 (0.35%)  1 0/274 (0.00%)  0 1/284 (0.35%)  1
Sepsis  1  1/273 (0.37%)  1 0/285 (0.00%)  0 1/274 (0.36%)  1 0/284 (0.00%)  0
Skin infection  1  0/273 (0.00%)  0 2/285 (0.70%)  2 2/274 (0.73%)  2 0/284 (0.00%)  0
Urinary tract infection  1  1/273 (0.37%)  1 0/285 (0.00%)  0 0/274 (0.00%)  0 1/284 (0.35%)  1
Wound infection  1  0/273 (0.00%)  0 1/285 (0.35%)  1 0/274 (0.00%)  0 1/284 (0.35%)  1
Ovarian infection  1  1/273 (0.37%)  1 0/285 (0.00%)  0 1/274 (0.36%)  1 0/284 (0.00%)  0
Lung infection  1  0/273 (0.00%)  0 3/285 (1.05%)  3 0/274 (0.00%)  0 3/284 (1.06%)  3
Injury, poisoning and procedural complications         
Fall  1  1/273 (0.37%)  1 0/285 (0.00%)  0 0/274 (0.00%)  0 1/284 (0.35%)  1
Fracture  1  1/273 (0.37%)  1 1/285 (0.35%)  1 1/274 (0.36%)  1 1/284 (0.35%)  1
Injury, poisoning and procedural complications - Other, specify  1  0/273 (0.00%)  0 2/285 (0.70%)  2 2/274 (0.73%)  2 0/284 (0.00%)  0
Spinal fracture  1  1/273 (0.37%)  1 0/285 (0.00%)  0 1/274 (0.36%)  1 0/284 (0.00%)  0
Postoperative hemorrhage  1  1/273 (0.37%)  1 0/285 (0.00%)  0 0/274 (0.00%)  0 1/284 (0.35%)  1
Investigations         
Creatinine increased  1  0/273 (0.00%)  0 1/285 (0.35%)  1 0/274 (0.00%)  0 1/284 (0.35%)  1
Metabolism and nutrition disorders         
Dehydration  1  0/273 (0.00%)  0 3/285 (1.05%)  3 3/274 (1.09%)  3 0/284 (0.00%)  0
Hyperglycemia  1  0/273 (0.00%)  0 1/285 (0.35%)  1 1/274 (0.36%)  1 0/284 (0.00%)  0
Obesity  1  0/273 (0.00%)  0 1/285 (0.35%)  1 0/274 (0.00%)  0 1/284 (0.35%)  1
Musculoskeletal and connective tissue disorders         
Back pain  1  0/273 (0.00%)  0 2/285 (0.70%)  2 1/274 (0.36%)  1 1/284 (0.35%)  1
Chest wall pain  1  2/273 (0.73%)  2 3/285 (1.05%)  3 3/274 (1.09%)  3 2/284 (0.70%)  2
Musculoskeletal and connective tissue disorder - Other, specify  1  0/273 (0.00%)  0 1/285 (0.35%)  1 1/274 (0.36%)  1 0/284 (0.00%)  0
Neck pain  1  0/273 (0.00%)  0 1/285 (0.35%)  1 0/274 (0.00%)  0 1/284 (0.35%)  1
Musculoskeletal deformity  1  0/273 (0.00%)  0 1/285 (0.35%)  1 1/274 (0.36%)  1 0/284 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify  1  1/273 (0.37%)  1 4/285 (1.40%)  4 4/274 (1.46%)  4 1/284 (0.35%)  1
Nervous system disorders         
Akathisia  1  1/273 (0.37%)  1 0/285 (0.00%)  0 0/274 (0.00%)  0 1/284 (0.35%)  1
Depressed level of consciousness  1  0/273 (0.00%)  0 1/285 (0.35%)  1 0/274 (0.00%)  0 1/284 (0.35%)  1
Dizziness  1  1/273 (0.37%)  1 0/285 (0.00%)  0 0/274 (0.00%)  0 1/284 (0.35%)  1
Headache  1  1/273 (0.37%)  1 4/285 (1.40%)  5 2/274 (0.73%)  2 3/284 (1.06%)  4
Intracranial hemorrhage  1  0/273 (0.00%)  0 1/285 (0.35%)  1 0/274 (0.00%)  0 1/284 (0.35%)  1
Ischemia cerebrovascular  1  1/273 (0.37%)  2 0/285 (0.00%)  0 1/274 (0.36%)  2 0/284 (0.00%)  0
Lethargy  1  0/273 (0.00%)  0 1/285 (0.35%)  1 0/274 (0.00%)  0 1/284 (0.35%)  1
Nervous system disorders - Other, specify  1  3/273 (1.10%)  3 1/285 (0.35%)  1 1/274 (0.36%)  1 3/284 (1.06%)  3
Peripheral sensory neuropathy  1  1/273 (0.37%)  1 0/285 (0.00%)  0 0/274 (0.00%)  0 1/284 (0.35%)  1
Stroke  1  1/273 (0.37%)  1 0/285 (0.00%)  0 1/274 (0.36%)  1 0/284 (0.00%)  0
Syncope  1  0/273 (0.00%)  0 1/285 (0.35%)  1 1/274 (0.36%)  1 0/284 (0.00%)  0
Transient ischemic attacks  1  0/273 (0.00%)  0 1/285 (0.35%)  1 0/274 (0.00%)  0 1/284 (0.35%)  1
Vasovagal reaction  1  0/273 (0.00%)  0 1/285 (0.35%)  1 1/274 (0.36%)  1 0/284 (0.00%)  0
Pregnancy, puerperium and perinatal conditions         
Pregnancy, puerperium and perinatal conditions - Other, specify  1  9/273 (3.30%)  11 11/285 (3.86%)  14 10/274 (3.65%)  13 10/284 (3.52%)  12
Premature delivery  1  0/273 (0.00%)  0 1/285 (0.35%)  1 1/274 (0.36%)  1 0/284 (0.00%)  0
Unintended pregnancy  1  0/273 (0.00%)  0 1/285 (0.35%)  1 0/274 (0.00%)  0 1/284 (0.35%)  1
Psychiatric disorders         
Anxiety  1  1/273 (0.37%)  1 1/285 (0.35%)  1 0/274 (0.00%)  0 2/284 (0.70%)  2
Depression  1  0/273 (0.00%)  0 2/285 (0.70%)  2 1/274 (0.36%)  1 1/284 (0.35%)  1
Psychiatric disorders - Other, specify  1  1/273 (0.37%)  1 0/285 (0.00%)  0 1/274 (0.36%)  1 0/284 (0.00%)  0
Suicidal ideation  1  0/273 (0.00%)  0 1/285 (0.35%)  1 0/274 (0.00%)  0 1/284 (0.35%)  1
Suicide attempt  1  1/273 (0.37%)  1 2/285 (0.70%)  2 1/274 (0.36%)  1 2/284 (0.70%)  2
Renal and urinary disorders         
Renal and urinary disorders - Other, specify  1  7/273 (2.56%)  8 6/285 (2.11%)  7 9/274 (3.28%)  10 4/284 (1.41%)  5
Renal calculi  1  1/273 (0.37%)  1 2/285 (0.70%)  2 0/274 (0.00%)  0 3/284 (1.06%)  3
Renal colic  1  2/273 (0.73%)  2 2/285 (0.70%)  2 0/274 (0.00%)  0 4/284 (1.41%)  4
Renal hemorrhage  1  1/273 (0.37%)  1 1/285 (0.35%)  1 1/274 (0.36%)  1 1/284 (0.35%)  1
Urinary incontinence  1  0/273 (0.00%)  0 2/285 (0.70%)  2 1/274 (0.36%)  1 1/284 (0.35%)  1
Urinary tract obstruction  1  2/273 (0.73%)  2 0/285 (0.00%)  0 1/274 (0.36%)  1 1/284 (0.35%)  1
Acute kidney injury  1  0/273 (0.00%)  0 1/285 (0.35%)  1 0/274 (0.00%)  0 1/284 (0.35%)  1
Reproductive system and breast disorders         
Breast atrophy  1  0/273 (0.00%)  0 1/285 (0.35%)  1 1/274 (0.36%)  1 0/284 (0.00%)  0
Menorrhagia  1  0/273 (0.00%)  0 1/285 (0.35%)  1 1/274 (0.36%)  1 0/284 (0.00%)  0
Pelvic pain  1  1/273 (0.37%)  1 0/285 (0.00%)  0 0/274 (0.00%)  0 1/284 (0.35%)  1
Reproductive system and breast disorders - Other, specify  1  2/273 (0.73%)  2 1/285 (0.35%)  1 2/274 (0.73%)  2 1/284 (0.35%)  1
Uterine pain  1  0/273 (0.00%)  0 1/285 (0.35%)  2 0/274 (0.00%)  0 1/284 (0.35%)  2
Vaginal hemorrhage  1  0/273 (0.00%)  0 1/285 (0.35%)  1 1/274 (0.36%)  1 0/284 (0.00%)  0
Uterine obstruction  1  1/273 (0.37%)  1 0/285 (0.00%)  0 1/274 (0.36%)  1 0/284 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Bronchospasm  1  0/273 (0.00%)  0 1/285 (0.35%)  2 1/274 (0.36%)  2 0/284 (0.00%)  0
Cough  1  1/273 (0.37%)  1 0/285 (0.00%)  0 0/274 (0.00%)  0 1/284 (0.35%)  1
Dyspnea  1  0/273 (0.00%)  0 1/285 (0.35%)  1 1/274 (0.36%)  1 0/284 (0.00%)  0
Pneumonitis  1  1/273 (0.37%)  1 1/285 (0.35%)  1 1/274 (0.36%)  1 1/284 (0.35%)  1
Pneumothorax  1  1/273 (0.37%)  2 1/285 (0.35%)  1 1/274 (0.36%)  2 1/284 (0.35%)  1
Respiratory, thoracic and mediastinal disorders - Other, specify  1  1/273 (0.37%)  1 0/285 (0.00%)  0 1/274 (0.36%)  1 0/284 (0.00%)  0
Surgical and medical procedures         
Surgical and medical procedures - Other, specify  1  0/273 (0.00%)  0 7/285 (2.46%)  7 2/274 (0.73%)  2 5/284 (1.76%)  5
Vascular disorders         
Hypertension  1  1/273 (0.37%)  2 0/285 (0.00%)  0 1/274 (0.36%)  2 0/284 (0.00%)  0
Thromboembolic event  1  0/273 (0.00%)  0 2/285 (0.70%)  3 0/274 (0.00%)  0 2/284 (0.70%)  3
Vascular disorders - Other, specify  1  0/273 (0.00%)  0 1/285 (0.35%)  1 0/274 (0.00%)  0 1/284 (0.35%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
ACE-I + ARB ACE-I Alone Low Blood Pressure Group Standard Blood Pressure Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   23/273 (8.42%)      21/285 (7.37%)      23/274 (8.39%)      21/284 (7.39%)    
Metabolism and nutrition disorders         
Hyperkalemia  1  11/273 (4.03%)  13 5/285 (1.75%)  6 7/274 (2.55%)  8 9/284 (3.17%)  11
Renal and urinary disorders         
Acute kidney injury * 1  13/273 (4.76%)  15 16/285 (5.61%)  19 16/274 (5.84%)  17 13/284 (4.58%)  17
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Arlene Chapman
Organization: Emory University
Phone: (404) 712‐1993
EMail: abchapm@emory.edu
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Charity G Moore, PhD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00283686     History of Changes
Other Study ID Numbers: DK62401-PKD-TN (IND)
First Submitted: January 26, 2006
First Posted: January 30, 2006
Results First Submitted: February 9, 2015
Results First Posted: February 27, 2015
Last Update Posted: March 19, 2015