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

This study has been completed.
Sponsor:
Collaborators:
Boehringer Ingelheim
Merck Sharp & Dohme Corp.
Polycystic Kidney Disease Foundation
Information provided by (Responsible Party):
Charity G Moore, PhD, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00283686
First received: January 26, 2006
Last updated: March 18, 2015
Last verified: March 2015
Results First Received: February 9, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Double Blind (Subject, Caregiver, 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled at seven clinical sites between February 2006 and June 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
ACE-I/ARB and Standard BP

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/ARB and Low BP

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 BP

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 BP

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.


Participant Flow:   Overall Study
    ACE-I/ARB and Standard BP   ACE-I/ARB and Low BP   ACE-I/Placebo and Standard BP   ACE-I/Placebo and Low BP
STARTED   140   133   144   141 
COMPLETED   111   92   111   109 
NOT COMPLETED   29   41   33   32 
Death                1                1                1                0 
Lost to Follow-up                21                31                26                20 
Less than full participation                7                9                6                12 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
ACE-I/ARB and Standard BP

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 BP

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 BP

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 BP

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 Total of all reporting groups

Baseline Measures
   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 
Overall Participants Analyzed 
[Units: Participants]
 140   133   144   141   558 
Age 
[Units: Years]
Mean (Standard Deviation)
 37.0  (8.3)   37.1  (8.4)   35.8  (8.6)   36.8  (8.0)   36.7  (8.3) 
Gender 
[Units: Participants]
         
Female   68   64   73   70   275 
Male   72   69   71   71   283 
Race (NIH/OMB) 
[Units: Participants]
         
American Indian or Alaska Native   1   0   2   2   5 
Asian   1   1   2   1   5 
Native Hawaiian or Other Pacific Islander   0   0   0   0   0 
Black or African American   4   2   3   5   14 
White   127   128   131   131   517 
More than one race   5   2   6   2   15 
Unknown or Not Reported   2   0   0   0   2 
Age at Diagnosis of autosomal dominant polycystic kidney disease (ADPKD) 
[Units: Years]
Mean (Standard Deviation)
 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) 
[Units: Kg/m2]
Mean (Standard Deviation)
 27.4  (5.4)   27.4  (5.1)   27.3  (5.5)   26.8  (4.8)   27.2  (5.2) 
Serum Creatinine (mg/dl) 
[Units: Mg/dl]
Mean (Standard Deviation)
 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) 
[Units: Ml/min/m2]
Mean (Standard Deviation)
 88.5  (18.8)   86.5  (19.3)   92.9  (18.5)   87.6  (17.2)   88.9  (18.5) 
PKD Genotype 
[Units: 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 


  Outcome Measures
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1.  Primary:   Study A: Percent Annual Change in Total Kidney Volume   [ Time Frame: Baseline and 2-, 4- and 5-year follow-up ]

2.  Secondary:   Kidney Function (eGFR)   [ Time Frame: Up to 96 months (6 month assessments) ]

3.  Secondary:   Albuminuria   [ Time Frame: Up to 96 months (assessed annually) ]

4.  Secondary:   Aldosterone   [ Time Frame: Up to 96 months (assessed annually) ]

5.  Secondary:   Left Ventricular Mass Index   [ Time Frame: 0, 24 months, 48 months, 60 months ]

6.  Secondary:   Renal Blood Flow   [ Time Frame: 0, 24 months, 48 months, 60 months ]

7.  Secondary:   All-Cause Hospitalizations   [ Time Frame: Up to 96 months ]

8.  Secondary:   Quality of Life Physical Component Summary   [ Time Frame: baseline, 12, 24, 36, 48, 60, 72, 84, and 96 months (assessed annually) ]

9.  Secondary:   Quality of Life Mental Component Summary   [ Time Frame: baseline, 12, 24, 36, 48, 60, 72, 84, and 96 months (assessed annually) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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:  
Name/Title: Dr. Arlene Chapman
Organization: Emory University
phone: (404) 712‐1993
e-mail: abchapm@emory.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Charity G Moore, PhD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00283686     History of Changes
Other Study ID Numbers: DK62401-PKD-TN (IND)
Study First Received: January 26, 2006
Results First Received: February 9, 2015
Last Updated: March 18, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
United States: Federal Government