Trial Outcomes & Findings for Safe Kidney Care Cohort Study (NCT NCT01407367)
NCT ID: NCT01407367
Last Updated: 2019-10-18
Results Overview
The discrete incidence of any of the following CKD-PSIs endorsed by the consensus expert panel: Class I events: Incidence of patient reported adverse events related to medical care or medicines incuding: Falling, Bleeding, Edema, Angioedema, Confusion or altered mental status, Rhabdomyolysis Class II events: Incidence of adverse events detected at annual study visits such as: Hyperkalemia, Hypokalemia, Hypoglycemia, Hyperglycemia, Orthostatic Hypotension, Hypotension, Hypertension, Bradycardia Class III events: Incidence of usage of medications or agents to be avoided in CKD and Incidence of improperly dosed medications in CKD
COMPLETED
350 participants
at the end of study (up to 4.25 years, depending on participant enrollment date)
2019-10-18
Participant Flow
Participant milestones
| Measure |
Phase I
Phase I (first 108 participants enrolled) Medical alert bracelet/necklace, Medical event diary, Medical event ascertainment, Repeated measurement of renal function and other electrolytes, Review for CKD-PSIs
|
Phase II
Phase II (subsequent 242 participants enrolled) Medical event diary, Medical event ascertainment, Repeated measurement of renal function and other electrolytes, Review for CKD-PSIs
|
|---|---|---|
|
Overall Study
STARTED
|
108
|
242
|
|
Overall Study
COMPLETED
|
68
|
164
|
|
Overall Study
NOT COMPLETED
|
40
|
78
|
Reasons for withdrawal
| Measure |
Phase I
Phase I (first 108 participants enrolled) Medical alert bracelet/necklace, Medical event diary, Medical event ascertainment, Repeated measurement of renal function and other electrolytes, Review for CKD-PSIs
|
Phase II
Phase II (subsequent 242 participants enrolled) Medical event diary, Medical event ascertainment, Repeated measurement of renal function and other electrolytes, Review for CKD-PSIs
|
|---|---|---|
|
Overall Study
Death
|
24
|
32
|
|
Overall Study
Renal Replacement Therapy (RRT)
|
12
|
29
|
|
Overall Study
Withdrawal by Subject
|
4
|
15
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
Baseline Characteristics
Safe Kidney Care Cohort Study
Baseline characteristics by cohort
| Measure |
Phase I
n=108 Participants
Phase I (first 108 participants enrolled):
Medical alert bracelet/necklace, Medical event diary, Medical event ascertainment, Repeated measurement of renal function and other electrolytes, Review for CKD-PSIs
|
Phase II
n=242 Participants
Phase II (subsequent 242 participants enrolled):
Medical event diary, Medical event ascertainment, Repeated measurement of renal function and other electrolytes, Review for CKD-PSIs
|
Total
n=350 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Black or African American
|
78 Participants
n=5 Participants
|
165 Participants
n=7 Participants
|
243 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
56 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
52 Participants
n=5 Participants
|
152 Participants
n=7 Participants
|
204 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=5 Participants
|
181 Participants
n=7 Participants
|
251 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
108 Participants
n=5 Participants
|
242 Participants
n=7 Participants
|
350 Participants
n=5 Participants
|
|
eGFR
Stage 2 (60 ≤ eGFR ≤ 89 mL/min/1.73 m²)
|
12 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
eGFR
Stage 3a (45 ≤ eGFR ≤ 59 mL/min/1.73 m²,)
|
32 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
eGFR
Stage 3b (30 ≤ eGFR ≤ 44 mL/min/1.73 m²,)
|
46 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
|
eGFR
Stage 4 (15 ≤ eGFR ≤ 29 mL/min/1.73 m²,)
|
15 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
eGFR
Stage 5 (eGFR< 15 mL/min/1.73 m²,)
|
3 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at the end of study (up to 4.25 years, depending on participant enrollment date)Population: Safety events reported in this outcome measure are from 6 months prior to participant's annual in-center visits
The discrete incidence of any of the following CKD-PSIs endorsed by the consensus expert panel: Class I events: Incidence of patient reported adverse events related to medical care or medicines incuding: Falling, Bleeding, Edema, Angioedema, Confusion or altered mental status, Rhabdomyolysis Class II events: Incidence of adverse events detected at annual study visits such as: Hyperkalemia, Hypokalemia, Hypoglycemia, Hyperglycemia, Orthostatic Hypotension, Hypotension, Hypertension, Bradycardia Class III events: Incidence of usage of medications or agents to be avoided in CKD and Incidence of improperly dosed medications in CKD
Outcome measures
| Measure |
Phase I
n=108 Participants
Phase I Phase I (first 108 participants enrolled) Medical alert bracelet/necklace, Medical event diary, Medical event ascertainment, Repeated measurement of renal function and other electrolytes, Review for CKD-PSIs
|
Phase II
n=242 Participants
Phase II Medical event diary, Medical event ascertainment, Repeated measurement of renal function and other electrolytes, Review for CKD-PSIs
|
|---|---|---|
|
The Discrete Incidence of Any of the Chronic Kidney Disease Patient Safety Indicators (CKD-PSIs) Endorsed by the Consensus Expert Panel
Class I
|
108.7 events per 100 patient-visits
|
100.6 events per 100 patient-visits
|
|
The Discrete Incidence of Any of the Chronic Kidney Disease Patient Safety Indicators (CKD-PSIs) Endorsed by the Consensus Expert Panel
Class II
|
38.3 events per 100 patient-visits
|
41.2 events per 100 patient-visits
|
SECONDARY outcome
Timeframe: at the end of study (up to 4.25 years, depending on participant enrollment date)Hospitalizations (following enrollment); including length of stay and safety events during hospitalization until time of end of study.
Outcome measures
| Measure |
Phase I
n=108 Participants
Phase I Phase I (first 108 participants enrolled) Medical alert bracelet/necklace, Medical event diary, Medical event ascertainment, Repeated measurement of renal function and other electrolytes, Review for CKD-PSIs
|
Phase II
n=242 Participants
Phase II Medical event diary, Medical event ascertainment, Repeated measurement of renal function and other electrolytes, Review for CKD-PSIs
|
|---|---|---|
|
Rate of All-cause Hospitalization
|
0.51 events per patient-years
|
0.44 events per patient-years
|
SECONDARY outcome
Timeframe: at the end of study (up to 4.25 years, depending on participant enrollment date)Renal function with estimated glomerular filtration rate (eGFR) based on serum creatinine measured annually until time of end of study.
Outcome measures
| Measure |
Phase I
n=108 Participants
Phase I Phase I (first 108 participants enrolled) Medical alert bracelet/necklace, Medical event diary, Medical event ascertainment, Repeated measurement of renal function and other electrolytes, Review for CKD-PSIs
|
Phase II
n=242 Participants
Phase II Medical event diary, Medical event ascertainment, Repeated measurement of renal function and other electrolytes, Review for CKD-PSIs
|
|---|---|---|
|
Change in Renal Function From Baseline
|
-0.12 ml/min per 1.73m^2 per month
Interval -0.35 to 0.08
|
-0.06 ml/min per 1.73m^2 per month
Interval -0.38 to 0.16
|
SECONDARY outcome
Timeframe: at the end of study (up to 4.25 years, depending on participant enrollment date)ESRD defined as the need for renal replacement therapy with either dialysis (hemodialysis or peritoneal) for 3 months or more; or renal transplantation up until the time of end of study.
Outcome measures
| Measure |
Phase I
n=108 Participants
Phase I Phase I (first 108 participants enrolled) Medical alert bracelet/necklace, Medical event diary, Medical event ascertainment, Repeated measurement of renal function and other electrolytes, Review for CKD-PSIs
|
Phase II
n=242 Participants
Phase II Medical event diary, Medical event ascertainment, Repeated measurement of renal function and other electrolytes, Review for CKD-PSIs
|
|---|---|---|
|
Number of Participants With End-stage Renal Disease (ESRD) Defined as Need for Renal Replacement Therapy (Dialysis or Transplant)
|
12 participants
|
29 participants
|
SECONDARY outcome
Timeframe: at the end of study (up to 4.25 years, depending on participant enrollment date)determined until end of study.
Outcome measures
| Measure |
Phase I
n=108 Participants
Phase I Phase I (first 108 participants enrolled) Medical alert bracelet/necklace, Medical event diary, Medical event ascertainment, Repeated measurement of renal function and other electrolytes, Review for CKD-PSIs
|
Phase II
n=242 Participants
Phase II Medical event diary, Medical event ascertainment, Repeated measurement of renal function and other electrolytes, Review for CKD-PSIs
|
|---|---|---|
|
Number of Deaths Among Participants (All-cause)
|
24 participants
|
32 participants
|
Adverse Events
Phase I
Phase II
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jeffrey C. Fink MD, MS; Principal Investigator
University of Maryland Baltimore
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place