Trial Outcomes & Findings for PREVENTKD (Prevent Risks by Early interVEntion at Nighttime in Type 1 Diabetes for Kidney Disease) (NCT NCT00729365)
NCT ID: NCT00729365
Last Updated: 2015-03-17
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
65 participants
Primary outcome timeframe
at 3months and then every 6months during the 5years of the study
Results posted on
2015-03-17
Participant Flow
Participant milestones
| Measure |
Dippers - Placebo Group
Subjects with normal nighttime blood pressure profile that decreases at night (Dippers). This group are all given placebo.
Placebo: Dippers (category of subjects with a nighttime dip in blood pressure) will all be given Placebo. Control group.
|
Non-dippers - Placebo
Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given placebo.
Placebo: Subjects with nighttime blood pressure that does not drop during the night ("non-dippers") maybe randomized into the control group and given Placebo.
|
Non-Dippers - Ramipril
Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given ACE inhibitor (study medication).
Ramipril: ACE inhibitor known as Ramipril
Subjects with nighttime blood pressure that does not drop during the night ("non-dippers") maybe randomized into this group and given an ACE inhibitor (study medication). Therefore, the "Non-Dippers" groups II and III will be randomized to receive either drug or placebo.
|
|---|---|---|---|
|
Overall Study
STARTED
|
33
|
6
|
7
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
33
|
6
|
7
|
Reasons for withdrawal
| Measure |
Dippers - Placebo Group
Subjects with normal nighttime blood pressure profile that decreases at night (Dippers). This group are all given placebo.
Placebo: Dippers (category of subjects with a nighttime dip in blood pressure) will all be given Placebo. Control group.
|
Non-dippers - Placebo
Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given placebo.
Placebo: Subjects with nighttime blood pressure that does not drop during the night ("non-dippers") maybe randomized into the control group and given Placebo.
|
Non-Dippers - Ramipril
Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given ACE inhibitor (study medication).
Ramipril: ACE inhibitor known as Ramipril
Subjects with nighttime blood pressure that does not drop during the night ("non-dippers") maybe randomized into this group and given an ACE inhibitor (study medication). Therefore, the "Non-Dippers" groups II and III will be randomized to receive either drug or placebo.
|
|---|---|---|---|
|
Overall Study
Physician Decision
|
33
|
6
|
7
|
Baseline Characteristics
PREVENTKD (Prevent Risks by Early interVEntion at Nighttime in Type 1 Diabetes for Kidney Disease)
Baseline characteristics by cohort
| Measure |
Dippers - Placebo
n=33 Participants
Subjects with normal nighttime blood pressure profile that decreases at night (Dippers). This group are all given placebo.
Placebo: Dippers (category of subjects with a nighttime dip in blood pressure) will all be given Placebo. Control group.
|
Non-Dippers - Placebo
n=6 Participants
Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given placebo.
Placebo: Subjects with nighttime blood pressure that does not drop during the night ("non-dippers") maybe randomized into the control group and given Placebo.
|
Non-Dippers - Ramipril
n=7 Participants
Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given ACE inhibitor (study medication).
Ramipril: ACE inhibitor known as Ramipril
Subjects with nighttime blood pressure that does not drop during the night ("non-dippers") maybe randomized into this group and given an ACE inhibitor (study medication). Therefore, the "Non-Dippers" groups II and III will be randomized to receive either drug or placebo.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
30.0 years
n=5 Participants
|
27.5 years
n=7 Participants
|
30.0 years
n=5 Participants
|
29.5 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
6 participants
n=7 Participants
|
7 participants
n=5 Participants
|
46 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: at 3months and then every 6months during the 5years of the studyOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: year 1, 3, 5 and after the washout phase (5years and 1month)Outcome measures
Outcome data not reported
Adverse Events
Dippers - Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-Dippers - Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-Dippers - Ramipril
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Mark E. Molitch
Northwestern University Feinberg School of Medicine
Phone: 312 503-4130
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place