Trial Outcomes & Findings for Lipid Management in Renal Transplant Recipients Using Evolocumab. (NCT NCT04608474)
NCT ID: NCT04608474
Last Updated: 2026-04-16
Results Overview
The primary efficacy measure is the percent change in LDL cholesterol from baseline to 12 months. The 12-month LDL value is defined as the measurement closest to 12 months within a prespecified window of Months 11 to 13 following treatment initiation. LDL cholesterol is measured in mg/dL.
COMPLETED
PHASE4
81 participants
Baseline to 12 months (Month 0 to Month 12; assessment window Months 11-13)
2026-04-16
Participant Flow
Participant milestones
| Measure |
Evolocumab
Participants received evolocumab for lipid lowering following renal transplantation. Evolocumab was administered subcutaneously at standard dosing regimens of either 140 mg every 2 weeks or 420 mg monthly, in accordance with clinical practice.
|
|---|---|
|
Overall Study
STARTED
|
81
|
|
Overall Study
COMPLETED
|
50
|
|
Overall Study
NOT COMPLETED
|
31
|
Reasons for withdrawal
| Measure |
Evolocumab
Participants received evolocumab for lipid lowering following renal transplantation. Evolocumab was administered subcutaneously at standard dosing regimens of either 140 mg every 2 weeks or 420 mg monthly, in accordance with clinical practice.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
15
|
|
Overall Study
Withdrawal by Subject
|
9
|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Physician Decision
|
2
|
Baseline Characteristics
Seventy subjects received at least one dose of study treatment and comprise the analysis population. Baseline laboratory data were missing for four subjects; as a result, the number analyzed for baseline laboratory measures is 66.
Baseline characteristics by cohort
| Measure |
Evolocumab
n=70 Participants
Participants received evolocumab for lipid lowering following renal transplantation. Evolocumab was administered subcutaneously at standard dosing regimens of either 140 mg every 2 weeks or 420 mg monthly, in accordance with clinical practice.
|
|---|---|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=70 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
65 Participants
n=70 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=70 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=70 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=70 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=70 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=70 Participants
|
|
Race (NIH/OMB)
White
|
53 Participants
n=70 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=70 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=70 Participants
|
|
LDL Cholesterol, Baseline
|
131.5 mg/dL
STANDARD_DEVIATION 30.9 • n=66 Participants • Seventy subjects received at least one dose of study treatment and comprise the analysis population. Baseline laboratory data were missing for four subjects; as a result, the number analyzed for baseline laboratory measures is 66.
|
|
Age, Continuous
|
52.85 years
STANDARD_DEVIATION 12.34 • n=70 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=70 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=70 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 months (Month 0 to Month 12; assessment window Months 11-13)Population: Participants with both baseline LDL measurements and at least one LDL measurement within Months 11 to 13.
The primary efficacy measure is the percent change in LDL cholesterol from baseline to 12 months. The 12-month LDL value is defined as the measurement closest to 12 months within a prespecified window of Months 11 to 13 following treatment initiation. LDL cholesterol is measured in mg/dL.
Outcome measures
| Measure |
Evolocumab
n=43 Participants
Participants received evolocumab for lipid lowering following renal transplantation. Evolocumab was administered subcutaneously at standard dosing regimens of either 140 mg every 2 weeks or 420 mg monthly, in accordance with clinical practice.
|
|---|---|
|
Percent Change in LDL Cholesterol From Baseline to 12 Months
|
-46.6 Percent (%)
Standard Deviation 25.9
|
SECONDARY outcome
Timeframe: Baseline to 12 months (Month 0 to Month 12; assessment window Months 11-13)Population: Participants with baseline LDL measurements and at least one LDL measurement within Months 11 to 13.
Absolute change in LDL cholesterol from baseline to 12 months. The 12-month LDL value is defined as the measurement closest to 12 months within a prespecified window of Months 11 to 13 following treatment initiation. LDL cholesterol is measured in mg/dL.
Outcome measures
| Measure |
Evolocumab
n=43 Participants
Participants received evolocumab for lipid lowering following renal transplantation. Evolocumab was administered subcutaneously at standard dosing regimens of either 140 mg every 2 weeks or 420 mg monthly, in accordance with clinical practice.
|
|---|---|
|
Absolute Change in LDL Cholesterol From Baseline to 12 Months
|
-61.8 mg/dL
Standard Deviation 38.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline through Month 13Population: Participants with baseline LDL measurements and at least one LDL measurement during follow-up.
Number of participants who achieved LDL cholesterol \< 70 mg/dL at any time during follow-up.
Outcome measures
| Measure |
Evolocumab
n=66 Participants
Participants received evolocumab for lipid lowering following renal transplantation. Evolocumab was administered subcutaneously at standard dosing regimens of either 140 mg every 2 weeks or 420 mg monthly, in accordance with clinical practice.
|
|---|---|
|
Number of Participants Achieving LDL Cholesterol < 70 mg/dL at Any Time During Follow-up
Achieved LDL < 70 mg/dL
|
46 Participants
|
|
Number of Participants Achieving LDL Cholesterol < 70 mg/dL at Any Time During Follow-up
Did not achieve LDL < 70 mg/dL
|
20 Participants
|
Adverse Events
Evolocumab
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Evolocumab
n=66 participants at risk
Participants received evolocumab for lipid lowering following renal transplantation. Evolocumab was administered subcutaneously at standard dosing regimens of either 140 mg every 2 weeks or 420 mg monthly, in accordance with clinical practice.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Allergic Skin Reaction
|
4.5%
3/66 • 12 months
|
|
Investigations
Elevated Creatine Kinase
|
1.5%
1/66 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place