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  
Number of Participants  
[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
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  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


No publications provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Publications automatically indexed to this study:

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