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Renoprotection in Early Diabetic Nephropathy in Pima Indians

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ClinicalTrials.gov Identifier: NCT00340678
Recruitment Status : Completed
First Posted : June 21, 2006
Results First Posted : November 19, 2013
Last Update Posted : July 24, 2014
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Diabetic Nephropathy
Interventions Drug: Losartan
Drug: Placebo
Enrollment 170

Recruitment Details Subjects were enrolled between 1996 and 2001, the last biopsy was performed in 2007, and morphometric evaluation was completed in 2012.
Pre-assignment Details Of 313 patients with type 2 diabetes who were screened, 79 were ineligible, 50 declined to participate, and 14 had other reasons that prevented participation despite meeting eligibility requirements.
Arm/Group Title Normoalbuminuria Losartan Normoalbuminuria Placebo Microalbuminuria Losartan Microalbuminuria Placebo
Hide Arm/Group Description Subjects with normal urinary albumin excretion were treated with losartan began at 50 mg daily, with the dose increasing to 100 mg daily after 1 week if symptomatic hypotension did not develop. Subjects with normal urinary albumin excretion were treated with placebo corresponding to each dose of losartan. Subjects with microalbuminuria were treated with losartan began at 50 mg daily, with the dose increasing to 100 mg daily after 1 week if symptomatic hypotension did not develop. Subjects with Microalbuminuria were treated with placebo corresponding to each dose of losartan.
Period Title: Overall Study
Started 46 46 39 39
Completed 45 46 39 39
Not Completed 1 0 0 0
Reason Not Completed
Lost to Follow-up             1             0             0             0
Arm/Group Title Normoalbuminuria Losartan Normoalbuminuria Placebo Microalbuminuria Losartan Microalbuminuria Placebo Total
Hide Arm/Group Description Subjects with normal urinary albumin excretion were treated with losartan began at 50 mg daily, with the dose increasing to 100 mg daily after 1 week if symptomatic hypotension did not develop. Subjects with normal urinary albumin excretion were treated with placebo corresponding to each dose of losartan. Subjects with microalbuminuria were treated with losartan began at 50 mg daily, with the dose increasing to 100 mg daily after 1 week if symptomatic hypotension did not develop. Subjects with Microalbuminuria were treated with placebo corresponding to each dose of losartan. Total of all reporting groups
Overall Number of Baseline Participants 46 46 39 39 170
Hide Baseline Analysis Population Description
Of 170 subjects enrolled, one lost follow up. So all analysis was performed based on 169 subjects.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 46 participants 46 participants 39 participants 39 participants 170 participants
39.5  (10.6) 41.9  (11.7) 41.8  (8.9) 42.3  (10.9) 41.3  (10.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 46 participants 39 participants 39 participants 170 participants
Female
36
  78.3%
33
  71.7%
28
  71.8%
27
  69.2%
124
  72.9%
Male
10
  21.7%
13
  28.3%
11
  28.2%
12
  30.8%
46
  27.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 46 participants 46 participants 39 participants 39 participants 170 participants
46 46 39 39 170
Diabetes duration  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 46 participants 46 participants 39 participants 39 participants 170 participants
8.8  (4.7) 10.4  (6.0) 10.3  (5.2) 14.1  (8.4) 10.8  (6.2)
BMI   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/(m^2)
Number Analyzed 46 participants 46 participants 39 participants 39 participants 170 participants
37.4  (8.8) 36.6  (8.0) 34.6  (9.1) 33.8  (7.2) 35.7  (8.3)
[1]
Measure Description: Body Mass Index obtained by measuring the participant's height in meters and weight in kilograms.
Blood pressure, systolic  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 46 participants 46 participants 39 participants 39 participants 170 participants
115  (11) 118  (14) 118  (15) 123  (13) 118  (13)
Blood pressure, diastolic  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 46 participants 46 participants 39 participants 39 participants 170 participants
75  (7) 75  (7) 77  (9) 77  (7) 76  (7)
Blood pressure, mean  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 46 participants 46 participants 39 participants 39 participants 170 participants
88  (7) 89  (9) 90  (10) 92  (8) 90  (9)
HbA1c   [1] 
Mean (Standard Deviation)
Unit of measure:  %
Number Analyzed 46 participants 46 participants 39 participants 39 participants 170 participants
9.2  (2.0) 8.1  (2.2) 9.5  (2.3) 10.3  (2.1) 9.2  (2.1)
[1]
Measure Description: Glycosylated hemoglobin is an integrated measure of glycemic control that reflects an average glycemic level over the past 3 months.
Glomerular filtration rate (GFR)   [1] 
Mean (Standard Deviation)
Unit of measure:  mL/min
Number Analyzed 46 participants 46 participants 39 participants 39 participants 170 participants
171  (38) 152  (40) 166  (43) 168  (43) 164  (41)
[1]
Measure Description: Glomerular filtration rate was measured by the urinary clearance of iothalamate.
Urinary albumin to creatinine ratio  
Median (Inter-Quartile Range)
Unit of measure:  Mg/g
Number Analyzed 46 participants 46 participants 39 participants 39 participants 170 participants
15
(10 to 23)
14
(9 to 26)
66
(39 to 205)
80
(46 to 165)
47
(9 to 205)
1.Primary Outcome
Title Number of Participants With Decline in GFR
Hide Description Participants were monitored for up to 6 years. This is the number of participants who had a decline in GFR to less than or equal to 60 ml/min or to half the baseline value in subjects that enter the study with a GFR of less than 120 ml/min during the time of observation.
Time Frame Up to 6 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat
Arm/Group Title Normoalbuminuria Losartan Normoalbuminuria Placebo Microalbuminuria Losartan Microalbuminuria Placebo
Hide Arm/Group Description:
Subjects with normal urinary albumin excretion were treated with losartan began at 50 mg daily, with the dose increasing to 100 mg daily after 1 week if symptomatic hypotension did not develop.
Subjects with normal urinary albumin excretion were treated with placebo corresponding to each dose of losartan.
Subjects with microalbuminuria were treated with losartan began at 50 mg daily, with the dose increasing to 100 mg daily after 1 week if symptomatic hypotension did not develop.
Subjects with Microalbuminuria were treated with placebo corresponding to each dose of losartan.
Overall Number of Participants Analyzed 45 46 39 39
Measure Type: Number
Unit of Measure: participants
2 2 1 4
2.Secondary Outcome
Title Glomerular Volume
Hide Description [Not Specified]
Time Frame 6 years after first treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat
Arm/Group Title Normoalbuminuria Losartan Normoalbuminuria Placebo Microalbuminuria Losartan Microalbuminuria Placebo
Hide Arm/Group Description:
Subjects with normal urinary albumin excretion were treated with losartan began at 50 mg daily, with the dose increasing to 100 mg daily after 1 week if symptomatic hypotension did not develop.
Subjects with normal urinary albumin excretion were treated with placebo corresponding to each dose of losartan.
Subjects with microalbuminuria were treated with losartan began at 50 mg daily, with the dose increasing to 100 mg daily after 1 week if symptomatic hypotension did not develop.
Subjects with Microalbuminuria were treated with placebo corresponding to each dose of losartan.
Overall Number of Participants Analyzed 45 46 39 39
Mean (Standard Deviation)
Unit of Measure: *10^6 cubic microns
5.4  (1.8) 5.6  (1.1) 6.4  (2.3) 7.0  (3.0)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Losartan Placebo
Hide Arm/Group Description Subjects received losartan Subjects received placebo
All-Cause Mortality
Losartan Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Losartan Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/84 (3.57%)      6/85 (7.06%)    
Blood and lymphatic system disorders     
Death from coronary artery disease   1/84 (1.19%)  1 1/85 (1.18%)  1
Death from leukemia   0/84 (0.00%)  0 1/85 (1.18%)  1
Gastrointestinal disorders     
Death from bleeding gastric ulcer   1/84 (1.19%)  1 0/85 (0.00%)  0
General disorders     
Death from multiple myeloma   1/84 (1.19%)  1 0/85 (0.00%)  0
Hepatobiliary disorders     
Death from hepatocellular carcinoma   0/84 (0.00%)  0 1/85 (1.18%)  1
Death from alcoholic cirrhosis   0/84 (0.00%)  0 1/85 (1.18%)  1
Social circumstances     
Death from automobile accident   0/84 (0.00%)  0 2/85 (2.35%)  2
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Losartan Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/84 (1.19%)      0/85 (0.00%)    
Renal and urinary disorders     
Urethral obstruction after kidney biopsy   1/84 (1.19%)  1 0/85 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Renoprotection in Early Diabetic Nephropathy in Pima Indians
Organization: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phone: (602) 200-5205
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )
ClinicalTrials.gov Identifier: NCT00340678     History of Changes
Other Study ID Numbers: 999995037
OH95-DK-N037 ( Other Identifier: NIH/NIDDK )
First Submitted: June 19, 2006
First Posted: June 21, 2006
Results First Submitted: March 26, 2013
Results First Posted: November 19, 2013
Last Update Posted: July 24, 2014