Trial Outcomes & Findings for A Follow up Study of Patients Treated With Imlifidase Prior to Kidney Transplantation (NCT NCT03611621)
NCT ID: NCT03611621
Last Updated: 2025-02-07
Results Overview
The primary endpoint of this study is to determine overall graft survival, defined as time from transplantation to graft loss.
COMPLETED
31 participants
5 years after first dose of imlifidase (in the feeder study)
2025-02-07
Participant Flow
Long-term follow-up of patients participating in the imlifidase kidney transplantation studies (feeder studies) 13-HMedIdeS-02, 13-HMedIdeS-03, 14-HMedIdeS-04 and 15-HMedIdeS-06. The patients attend 4 follow up visits, 1, 2, 3 and 5 years after imlifidase administration. Up to 46 patients could be included depending on patients' willingness to participate in the trial.
Data from patients who died (n=3) or had lost their graft (n=3) after the end of the feeder study but prior to being enrolled in the current trial, were included in the data analysis after ethics permission i.e. data from 37 patients was analyzed.
Participant milestones
| Measure |
Imlifidase
All patients
|
|---|---|
|
Overall Study
STARTED
|
37
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Imlifidase
All patients
|
|---|---|
|
Overall Study
Graft loss
|
3
|
|
Overall Study
Death
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
A Follow up Study of Patients Treated With Imlifidase Prior to Kidney Transplantation
Baseline characteristics by cohort
| Measure |
Imlifidase
n=37 Participants
All patients
|
|---|---|
|
Age, Continuous
|
44.5 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
27 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
13 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
|
Region of Enrollment
France
|
2 participants
n=5 Participants
|
|
Height
|
171.4 cm
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Weight
|
72.2 kg
STANDARD_DEVIATION 15.1 • n=5 Participants
|
|
Body mass index (BMI)
|
24.2 kg/m2
STANDARD_DEVIATION 3.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: 5 years after first dose of imlifidase (in the feeder study)Population: The primary endpoint, overall graft survival, was analyzed by the Kaplan-Meier survival method and presented with 95% confidence limits. The following events were censored at the time of occurrence: withdrawal from the trial without graft loss, death not caused by graft loss, and end of trial without graft loss.
The primary endpoint of this study is to determine overall graft survival, defined as time from transplantation to graft loss.
Outcome measures
| Measure |
Imlifidase
n=37 Participants
All patients
|
|---|---|
|
Evaluation of Graft Survival in Subjects Who Have Undergone Kidney Transplantation After Imlifidase Administration.
|
91 percentage
Interval 75.0 to 97.0
|
SECONDARY outcome
Timeframe: 5 years after first dose of imlifidase (in the feeder study)Population: The overall patient survival was analyzed by the Kaplan-Meier survival method and presented with 95% confidence limits. The following events were censored: withdrawal from the trial while alive, and end of trial while alive
Overall patient survival defined as time from transplantation to death for any cause
Outcome measures
| Measure |
Imlifidase
n=37 Participants
All patients
|
|---|---|
|
Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Patient Survival.
|
92 percentage
Interval 77.0 to 97.0
|
SECONDARY outcome
Timeframe: 5 years after first dose of imlifidase (in the feeder study)Population: Patients with a visit/assessment at year 5
Kidney function as evaluated by estimated glomerular filtration rate (eGFR). eGFR was calculated according to the Modification of Diet in Renal Disease (MDRD) equation.
Outcome measures
| Measure |
Imlifidase
n=30 Participants
All patients
|
|---|---|
|
Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Kidney Function (Estimated Glomerular Filtration Rate (eGFR)).
|
50.74 mL/min/1.73m2
Standard Deviation 19.38
|
SECONDARY outcome
Timeframe: 5 years after first dose of imlifidase (in the feeder study)Population: Patients with a visit/assessment at year 5
Kidney function as evaluated by analysis of plasma (P)-creatinine
Outcome measures
| Measure |
Imlifidase
n=30 Participants
All patients
|
|---|---|
|
Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Kidney Function (Plasma (P)-Creatinine).
|
141.3 μmol/L
Standard Deviation 69.9
|
SECONDARY outcome
Timeframe: 5 years after first dose of imlifidase (in the feeder study)Population: Patients with a visit/assessment at year 5
Kidney function as evaluated by proteinuria by dipstick analysis
Outcome measures
| Measure |
Imlifidase
n=30 Participants
All patients
|
|---|---|
|
Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Kidney Function (Proteinuria).
Positive
|
14 Participants
|
|
Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Kidney Function (Proteinuria).
Negative
|
13 Participants
|
|
Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Kidney Function (Proteinuria).
Not done
|
3 Participants
|
SECONDARY outcome
Timeframe: 5 years after first dose of imlifidase (in the feeder study)Population: Patients with a visit/assessment at year 5. Note: number of patients with suspected acute rejection episodes up until year 5. One (1) biopsy confirmed rejection episode (AMR) was reported for 1 patient approx. 9 months after transplantation. One (1) biopsy confirmed rejection episode reported in the current trial occurred in the feeder trial. Five (5) rejection episodes were not confirmed by biopsy.
Recording of occurrence of graft rejection episodes classified by Banff criteria (Haas et al 2018). The following criteria had to be fulfilled by the rejection episode to constitute an antibody-mediated rejection (AMR): * a biopsy was taken at the time of the graft rejection episode * histological evidence of an AMR was reported in the pathology report * presence of detectable levels of donor specific antibodies (DSAs) and/or evidence of antibody-mediated morphological changes in the kidney transplant at the time of the biopsy
Outcome measures
| Measure |
Imlifidase
n=30 Participants
All patients
|
|---|---|
|
Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Number of Graft Rejection Episodes.
0 suspected acute rejection episodes
|
23 Participants
|
|
Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Number of Graft Rejection Episodes.
1 suspected acute rejection episode
|
7 Participants
|
SECONDARY outcome
Timeframe: 5 years after first dose of imlifidase (in the feeder study)Population: Patients with a visit/assessment at year 5. Any medication (e.g. Intravenous immunoglobulin \[IVIg\]) given for graft rejection episodes
Recording of graft rejection episodes treatments (e.g. dialysis, plasmapheresis and medications).
Outcome measures
| Measure |
Imlifidase
n=30 Participants
All patients
|
|---|---|
|
Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Treatment of Graft Rejection Episodes.
|
2 Participants
|
SECONDARY outcome
Timeframe: 5 years after first dose of imlifidase (in the feeder study)Population: All patients with a comorbidity reported. Note: any single patient could have more than one comorbidity reported.
Recording of comorbidities up until year 5 after treatment with imlifidase
Outcome measures
| Measure |
Imlifidase
n=18 Participants
All patients
|
|---|---|
|
Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Comorbidities.
urinary tract infection
|
9 participants with comorbidity
|
|
Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Comorbidities.
nasopharyngitis
|
3 participants with comorbidity
|
|
Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Comorbidities.
pyelonephritis
|
3 participants with comorbidity
|
|
Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Comorbidities.
upper respiratory infection
|
4 participants with comorbidity
|
|
Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Comorbidities.
Covid-19 infection
|
4 participants with comorbidity
|
|
Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Comorbidities.
urosepsis
|
2 participants with comorbidity
|
|
Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Comorbidities.
sepsis
|
2 participants with comorbidity
|
|
Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Comorbidities.
pneumonia
|
2 participants with comorbidity
|
|
Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Comorbidities.
diabetes mellitus
|
4 participants with comorbidity
|
SECONDARY outcome
Timeframe: 5 years after first dose of imlifidase (in the feeder study). Note: concomitant immunosuppressive medication up until year 5Population: Immunosuppressive medications were recorded for 30 of the 31 patients enrolled
Recording of concomitant immunosuppressive medication
Outcome measures
| Measure |
Imlifidase
n=30 Participants
All patients
|
|---|---|
|
Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Treatments of Comorbidities.
Tacrolimus
|
29 participants
|
|
Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Treatments of Comorbidities.
Belatacept
|
1 participants
|
|
Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Treatments of Comorbidities.
Mycophenolate
|
30 participants
|
|
Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Treatments of Comorbidities.
Prednisone/prednisolone
|
30 participants
|
SECONDARY outcome
Timeframe: 5 years after first dose of imlifidase (in the feeder study)Population: All patients with a visit/assessment at year 5
Blood samples were analyzed for hemoglobulin (Hb)
Outcome measures
| Measure |
Imlifidase
n=30 Participants
All patients
|
|---|---|
|
Assessment of Safety Laboratory Testing in Terms of Hematology (Hb)
|
121.5 g/L
Standard Deviation 35.3
|
SECONDARY outcome
Timeframe: 5 years after first dose of imlifidase (in the feeder study)Population: All patients with a visit/assessment at year 5. Note: not all patients had an assessment reported at year 5.
Differential analysis of leucocytes was done in blood samples
Outcome measures
| Measure |
Imlifidase
n=30 Participants
All patients
|
|---|---|
|
Assessment of Safety Laboratory Testing in Terms of Hematology (Differential Analysis of Leucocytes)
Basophils/Leucocytes
|
0.4 percentage
Standard Deviation 0.19
|
|
Assessment of Safety Laboratory Testing in Terms of Hematology (Differential Analysis of Leucocytes)
Eosinophils/Leucocytes
|
1.3 percentage
Standard Deviation 0.80
|
|
Assessment of Safety Laboratory Testing in Terms of Hematology (Differential Analysis of Leucocytes)
Lymphocytes/Leucocytes
|
20.3 percentage
Standard Deviation 8.71
|
|
Assessment of Safety Laboratory Testing in Terms of Hematology (Differential Analysis of Leucocytes)
Monocytes/Leucocytes
|
9.9 percentage
Standard Deviation 4.87
|
|
Assessment of Safety Laboratory Testing in Terms of Hematology (Differential Analysis of Leucocytes)
Neutrophils/Leucocytes
|
56.7 percentage
Standard Deviation 22.76
|
SECONDARY outcome
Timeframe: 5 years after first dose of imlifidase (in the feeder study)Population: All patients with a visit/assessment at year 5
Blood samples were analyzed for thrombocytes
Outcome measures
| Measure |
Imlifidase
n=30 Participants
All patients
|
|---|---|
|
Assessment of Safety Laboratory Testing in Terms of Hematology (Thrombocytes)
|
225 10^9 thrombocytes/L
Standard Deviation 65.8
|
SECONDARY outcome
Timeframe: 5 years after first dose of imlifidase (in the feeder study)Population: All patients with a visit/assessment at year 5.
Blood samples were analyzed for total IgG levels.
Outcome measures
| Measure |
Imlifidase
n=22 Participants
All patients
|
|---|---|
|
Assessment of Safety Laboratory Testing in Terms of Total Immunoglobulin G (IgG)
|
10.04 g/L
Standard Deviation 3.96
|
SECONDARY outcome
Timeframe: 5 years after first dose of imlifidase (in the feeder study)Population: All patients with a visit/assessment at year 5
DSA levels in blood samples were analyzed by Single Antigen Bead-Human Leukocyte Antigen (SAB-HLA) analysis
Outcome measures
| Measure |
Imlifidase
n=20 Participants
All patients
|
|---|---|
|
Assessment of Donor Specific Antibodies (DSA)
|
803 Mean fluorescence intensity (MFI)
Standard Deviation 2038
|
SECONDARY outcome
Timeframe: 5 years after first dose of imlifidase (in the feeder study)Population: All patients with a visit/assessment at year 5
Blood samples were analyzed for antibodies towards BK virus
Outcome measures
| Measure |
Imlifidase
n=28 Participants
All patients
|
|---|---|
|
Assessment of the Presence of BK Virus
Presence of BK virus
|
0 participants
|
|
Assessment of the Presence of BK Virus
No presence of BK virus
|
28 participants
|
SECONDARY outcome
Timeframe: 5 years after first dose of imlifidase (in the feeder study)Population: All patients with a visit/assessment at year 5
Serum samples were analyzed for anti-drug antibody (ADA) levels using an ImmunoCAP assay.
Outcome measures
| Measure |
Imlifidase
n=20 Participants
All patients
|
|---|---|
|
Assessment of the Immunogenicity of Imlifidase
|
26.70 mg/L
Standard Deviation 25.42
|
SECONDARY outcome
Timeframe: 5 years after first dose of imlifidase (in the feeder study)Population: All patients with a visit/assessment at year 5
Health related quality of life (HR-QoL) as evaluated by patient questionnaires EQ-5D-5 levels (5L) EQ-5D-5L index score values were calculated from individual health profiles by using the corresponding EQ-5D-5L crosswalk value set per country where a higher value correspond to better health. Index score value ranges per country: USA \[-0.109 - 1.000\], France \[-0.530 - 1.000\], Denmark \[-0.624 - 1.000\], since no index score values exist for Sweden, values for Denmark were used for patients from Sweden. The visual analogue scale (EQ VAS) score was graded from 0 (the worst imaginable health) to 100 (the best imaginable health), where higher scores correspond to better health.
Outcome measures
| Measure |
Imlifidase
n=27 Participants
All patients
|
|---|---|
|
Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Quality of Life (EQ-5D-5L).
EQ-5D-5L index value USA
|
0.86 score on a scale
Interval 0.55 to 1.0
|
|
Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Quality of Life (EQ-5D-5L).
EQ-5D-5L index value France
|
1.00 score on a scale
Interval 1.0 to 1.0
|
|
Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Quality of Life (EQ-5D-5L).
EQ-5D-5L index value Sweden
|
0.79 score on a scale
Interval 0.62 to 1.0
|
|
Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Quality of Life (EQ-5D-5L).
EQ VAS score
|
80.00 score on a scale
Interval 60.0 to 100.0
|
SECONDARY outcome
Timeframe: 5 years after first dose of imlifidase (in the feeder study)Population: All patients with a visit/assessment at year 5
Health related quality of life (HR-QoL) as evaluated by patient questionnaires Kidney Disease Quality of Life Questionnaire-short form (KDQOL-SF) Scores of different subscales were calculated according to the KDQOL-36 scoring program. The scale range for each subscale is 0 to 100, with higher scores indicating better quality of life.
Outcome measures
| Measure |
Imlifidase
n=27 Participants
All patients
|
|---|---|
|
Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Quality of Life (KDQOL-SF).
Burden of kidney disease
|
79.4 score on a scale
Standard Deviation 22.1
|
|
Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Quality of Life (KDQOL-SF).
Effects of kidney disease
|
89.0 score on a scale
Standard Deviation 9.9
|
|
Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Quality of Life (KDQOL-SF).
Overall health rating
|
76.0 score on a scale
Standard Deviation 13.4
|
|
Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Quality of Life (KDQOL-SF).
Cognitive function
|
86.9 score on a scale
Standard Deviation 18.0
|
|
Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Quality of Life (KDQOL-SF).
Physical functioning
|
86.0 score on a scale
Standard Deviation 17.6
|
|
Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Quality of Life (KDQOL-SF).
Work status
|
74.0 score on a scale
Standard Deviation 40.1
|
Adverse Events
Imlifidase
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place