VA NEPHRON-D: Diabetes iN Nephropathy Study

This study has been terminated.
(It was stopped primarily because of safety concerns along with low conditional power to detect a treatment effect on the primary outcome.)
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00555217
First received: November 7, 2007
Last updated: May 8, 2015
Last verified: May 2015
Results First Received: April 17, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver);   Primary Purpose: Treatment
Conditions: Kidney Disease
Nephropathy
Type 2 Diabetes
Interventions: Drug: losartan
Drug: lisinopril

  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
No text entered.

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
Combination of ARB and ACEI

Combination of an angiotensin converting enzyme inhibitor (ACEI) with an angiotensin receptor blocker (ARB)

losartan: 50 or 100mg/day

lisinopril: 10, 20 or 40 mg/day

Monotherapy ARB

Mono therapy arm. Standard treatment with angiotensin receptor blocker (ARB)

losartan: 50 or 100mg/day


Participant Flow:   Overall Study
    Combination of ARB and ACEI     Monotherapy ARB  
STARTED     724     724  
COMPLETED     649     656  
NOT COMPLETED     75     68  
Withdrawal by Subject                 35                 31  
Lost to Follow-up                 19                 20  
close out sites                 21                 17  



  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
Combination of ARB and ACEI

Combination of an angiotensin converting enzyme inhibitor (ACEI) with an angiotensin receptor blocker (ARB)

losartan: 50 or 100mg/day

lisinopril: 10, 20 or 40 mg/day

Monotherapy ARB

Mono therapy arm. Standard treatment with angiotensin receptor blocker (ARB)

losartan: 50 or 100mg/day

Total Total of all reporting groups

Baseline Measures
    Combination of ARB and ACEI     Monotherapy ARB     Total  
Number of Participants  
[units: participants]
  724     724     1448  
Age  
[units: years]
Mean (Standard Deviation)
  64.5  (7.9)     64.7  (7.7)     64.6  (7.8)  
Gender  
[units: participants]
     
Female     9     3     12  
Male     715     721     1436  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     71     75     146  
Not Hispanic or Latino     653     649     1302  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     16     25     41  
Asian     4     6     10  
Native Hawaiian or Other Pacific Islander     8     5     13  
Black or African American     172     160     332  
White     523     514     1037  
More than one race     0     14     14  
Unknown or Not Reported     1     0     1  
Region of Enrollment  
[units: participants]
     
United States     724     724     1448  
Body Mass Index  
[units: kg/m^2]
Mean (Standard Deviation)
  34.9  (6.7)     34.3  (6.9)     34.6  (6.8)  
Coronary Artery Disease  
[units: participants]
     
Yes     159     167     326  
No     565     557     1122  
Congestive Heart Failure  
[units: participants]
     
Yes     116     110     226  
No     608     614     1222  
Retinopathy  
[units: participants]
     
Yes     309     310     619  
No     415     414     829  
SBP  
[units: mmHg]
Mean (Standard Deviation)
  136.9  (16.5)     137.0  (16.0)     136.9  (16.3)  
DBP  
[units: mmHg]
Mean (Standard Deviation)
  72.5  (10.6)     72.8  (9.9)     72.7  (10.2)  
Total Cholesterol  
[units: mg/dl]
Mean (Standard Deviation)
  157.9  (43.6)     159.0  (40.5)     158.4  (42.1)  
LDL cholesterol  
[units: mg/dl]
Mean (Standard Deviation)
  81.6  (32.4)     84.3  (35.0)     82.9  (33.7)  
HDL cholesterol  
[units: mg/dl]
Mean (Standard Deviation)
  37.7  (11.0)     38.7  (11.3)     38.2  (11.2)  
Triglycerides  
[units: mg/dl]
Median (Inter-Quartile Range)
  165    (111 to 260)     162    (111 to 235)     163    (111 to 249)  
HbA1c  
[units: %]
Mean (Standard Deviation)
  7.8  (1.2)     7.8  (1.3)     7.8  (1.3)  
serum Creatinine at enrollment  
[units: mg/dl]
Mean (Standard Deviation)
  1.5  (0.4)     1.5  (0.4)     1.5  (0.4)  
Potassium  
[units: meq/L]
Mean (Standard Deviation)
  4.3  (0.5)     4.3  (0.5)     4.3  (0.5)  
eGFR at enrollment  
[units: ml/min/1.73m^2]
Mean (Standard Deviation)
  53.6  (15.5)     53.7  (16.2)     53.7  (15.9)  
urine albumin/creatinine at enrollment  
[units: mg/g]
Median (Inter-Quartile Range)
  841.5    (495 to 1698)     861.5    (487.5 to 1789)     851.0    (490 to 1752)  



  Outcome Measures
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1.  Primary:   A Composite Endpoint of Reduction in Estimated GFR of 30ml/Min/1.73m*m in Individuals w/a Baseline Estimated GFR >= 60 ml/Min/1.73m*m, Reduction in Estimated GFR >50% in Individuals w/ Baseline Estimated GFR <60ml/Min/1.73m*m; ESRD or Death   [ Time Frame: From enrollemnt to time of first primary event, up to 4.5 years ]

2.  Secondary:   A Renal Composite Endpoint, Defined as; Reduction in Estimated GFR of >50% (for Individuals With Baseline GFR <60) or Reduction in GFR of >30 (for Individuals With Baseline GFR >= GFR 60) or ESRD.   [ Time Frame: From enrollment to time of first event, up to 4.5 years ]


  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
In October, 2012 the DMC recommended that study treatment be stopped primarily because of safety concerns along with low conditional power to detect a treatment effect on the primary outcome.


  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: Linda Fried, MD, MPH
Organization: VA Pittsburgh Healthcare System and University of Pittsburgh School of Medicine, Pittsburgh, PA
phone: 412-360-3930
e-mail: Linda.Fried@va.gov


Publications of Results:
Other Publications:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00555217     History of Changes
Other Study ID Numbers: 565
Study First Received: November 7, 2007
Results First Received: April 17, 2015
Last Updated: May 8, 2015
Health Authority: United States: Federal Government