Trial Outcomes & Findings for Renoprotection in Early Diabetic Nephropathy in Pima Indians (NCT NCT00340678)
NCT ID: NCT00340678
Last Updated: 2021-03-25
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
170 participants
Primary outcome timeframe
Up to 6 years
Results posted on
2021-03-25
Participant Flow
Subjects were enrolled between 1996 and 2001, the last biopsy was performed in 2007, and morphometric evaluation was completed in 2012.
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.
Participant milestones
| Measure |
Normoalbuminuria Losartan
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.
|
Normoalbuminuria Placebo
Subjects with normal urinary albumin excretion were treated with placebo corresponding to each dose of losartan.
|
Microalbuminuria 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.
|
Microalbuminuria Placebo
Subjects with Microalbuminuria were treated with placebo corresponding to each dose of losartan.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
46
|
46
|
39
|
39
|
|
Overall Study
COMPLETED
|
45
|
46
|
39
|
39
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Normoalbuminuria Losartan
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.
|
Normoalbuminuria Placebo
Subjects with normal urinary albumin excretion were treated with placebo corresponding to each dose of losartan.
|
Microalbuminuria 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.
|
Microalbuminuria Placebo
Subjects with Microalbuminuria were treated with placebo corresponding to each dose of losartan.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Renoprotection in Early Diabetic Nephropathy in Pima Indians
Baseline characteristics by cohort
| Measure |
Normoalbuminuria Losartan
n=46 Participants
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.
|
Normoalbuminuria Placebo
n=46 Participants
Subjects with normal urinary albumin excretion were treated with placebo corresponding to each dose of losartan.
|
Microalbuminuria Losartan
n=39 Participants
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.
|
Microalbuminuria Placebo
n=39 Participants
Subjects with Microalbuminuria were treated with placebo corresponding to each dose of losartan.
|
Total
n=170 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
39.5 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
41.9 years
STANDARD_DEVIATION 11.7 • n=7 Participants
|
41.8 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
42.3 years
STANDARD_DEVIATION 10.9 • n=4 Participants
|
41.3 years
STANDARD_DEVIATION 10.6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
124 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
46 participants
n=5 Participants
|
46 participants
n=7 Participants
|
39 participants
n=5 Participants
|
39 participants
n=4 Participants
|
170 participants
n=21 Participants
|
|
Diabetes duration
|
8.8 years
STANDARD_DEVIATION 4.7 • n=5 Participants
|
10.4 years
STANDARD_DEVIATION 6.0 • n=7 Participants
|
10.3 years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
14.1 years
STANDARD_DEVIATION 8.4 • n=4 Participants
|
10.8 years
STANDARD_DEVIATION 6.2 • n=21 Participants
|
|
BMI
|
37.4 kg/(m^2)
STANDARD_DEVIATION 8.8 • n=5 Participants
|
36.6 kg/(m^2)
STANDARD_DEVIATION 8.0 • n=7 Participants
|
34.6 kg/(m^2)
STANDARD_DEVIATION 9.1 • n=5 Participants
|
33.8 kg/(m^2)
STANDARD_DEVIATION 7.2 • n=4 Participants
|
35.7 kg/(m^2)
STANDARD_DEVIATION 8.3 • n=21 Participants
|
|
Blood pressure, systolic
|
115 mmHg
STANDARD_DEVIATION 11 • n=5 Participants
|
118 mmHg
STANDARD_DEVIATION 14 • n=7 Participants
|
118 mmHg
STANDARD_DEVIATION 15 • n=5 Participants
|
123 mmHg
STANDARD_DEVIATION 13 • n=4 Participants
|
118 mmHg
STANDARD_DEVIATION 13 • n=21 Participants
|
|
Blood pressure, diastolic
|
75 mmHg
STANDARD_DEVIATION 7 • n=5 Participants
|
75 mmHg
STANDARD_DEVIATION 7 • n=7 Participants
|
77 mmHg
STANDARD_DEVIATION 9 • n=5 Participants
|
77 mmHg
STANDARD_DEVIATION 7 • n=4 Participants
|
76 mmHg
STANDARD_DEVIATION 7 • n=21 Participants
|
|
Blood pressure, mean
|
88 mmHg
STANDARD_DEVIATION 7 • n=5 Participants
|
89 mmHg
STANDARD_DEVIATION 9 • n=7 Participants
|
90 mmHg
STANDARD_DEVIATION 10 • n=5 Participants
|
92 mmHg
STANDARD_DEVIATION 8 • n=4 Participants
|
90 mmHg
STANDARD_DEVIATION 9 • n=21 Participants
|
|
HbA1c
|
9.2 %
STANDARD_DEVIATION 2.0 • n=5 Participants
|
8.1 %
STANDARD_DEVIATION 2.2 • n=7 Participants
|
9.5 %
STANDARD_DEVIATION 2.3 • n=5 Participants
|
10.3 %
STANDARD_DEVIATION 2.1 • n=4 Participants
|
9.2 %
STANDARD_DEVIATION 2.1 • n=21 Participants
|
|
Glomerular filtration rate (GFR)
|
171 mL/min
STANDARD_DEVIATION 38 • n=5 Participants
|
152 mL/min
STANDARD_DEVIATION 40 • n=7 Participants
|
166 mL/min
STANDARD_DEVIATION 43 • n=5 Participants
|
168 mL/min
STANDARD_DEVIATION 43 • n=4 Participants
|
164 mL/min
STANDARD_DEVIATION 41 • n=21 Participants
|
|
Urinary albumin to creatinine ratio
|
15 mg/g
n=5 Participants
|
14 mg/g
n=7 Participants
|
66 mg/g
n=5 Participants
|
80 mg/g
n=4 Participants
|
47 mg/g
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 6 yearsPopulation: Intention-to-treat
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.
Outcome measures
| Measure |
Normoalbuminuria Losartan
n=45 Participants
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.
|
Normoalbuminuria Placebo
n=46 Participants
Subjects with normal urinary albumin excretion were treated with placebo corresponding to each dose of losartan.
|
Microalbuminuria Losartan
n=39 Participants
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.
|
Microalbuminuria Placebo
n=39 Participants
Subjects with Microalbuminuria were treated with placebo corresponding to each dose of losartan.
|
|---|---|---|---|---|
|
Number of Participants With Decline in GFR
|
2 participants
|
2 participants
|
1 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 6 years after first treatmentPopulation: Intention-to-treat
Outcome measures
| Measure |
Normoalbuminuria Losartan
n=45 Participants
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.
|
Normoalbuminuria Placebo
n=46 Participants
Subjects with normal urinary albumin excretion were treated with placebo corresponding to each dose of losartan.
|
Microalbuminuria Losartan
n=39 Participants
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.
|
Microalbuminuria Placebo
n=39 Participants
Subjects with Microalbuminuria were treated with placebo corresponding to each dose of losartan.
|
|---|---|---|---|---|
|
Glomerular Volume
|
5.4 *10^6 cubic microns
Standard Deviation 1.8
|
5.6 *10^6 cubic microns
Standard Deviation 1.1
|
6.4 *10^6 cubic microns
Standard Deviation 2.3
|
7.0 *10^6 cubic microns
Standard Deviation 3.0
|
Adverse Events
Losartan
Serious events: 3 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Losartan
n=84 participants at risk
Subjects received losartan
|
Placebo
n=85 participants at risk
Subjects received placebo
|
|---|---|---|
|
Blood and lymphatic system disorders
Death from coronary artery disease
|
1.2%
1/84 • Number of events 1
|
1.2%
1/85 • Number of events 1
|
|
Blood and lymphatic system disorders
Death from leukemia
|
0.00%
0/84
|
1.2%
1/85 • Number of events 1
|
|
Hepatobiliary disorders
Death from hepatocellular carcinoma
|
0.00%
0/84
|
1.2%
1/85 • Number of events 1
|
|
Hepatobiliary disorders
Death from alcoholic cirrhosis
|
0.00%
0/84
|
1.2%
1/85 • Number of events 1
|
|
Social circumstances
Death from automobile accident
|
0.00%
0/84
|
2.4%
2/85 • Number of events 2
|
|
General disorders
Death from multiple myeloma
|
1.2%
1/84 • Number of events 1
|
0.00%
0/85
|
|
Gastrointestinal disorders
Death from bleeding gastric ulcer
|
1.2%
1/84 • Number of events 1
|
0.00%
0/85
|
Other adverse events
| Measure |
Losartan
n=84 participants at risk
Subjects received losartan
|
Placebo
n=85 participants at risk
Subjects received placebo
|
|---|---|---|
|
Renal and urinary disorders
Urethral obstruction after kidney biopsy
|
1.2%
1/84 • Number of events 1
|
0.00%
0/85
|
Additional Information
Dr. Robert Nelson
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phone: (602) 200-5205
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place