Trial Outcomes & Findings for An Long-term Follow-up Trial of Kidney Tx Patients Treated With Imlifidase or PE After an AMR (NCT NCT04711850)
NCT ID: NCT04711850
Last Updated: 2025-05-28
Results Overview
Graft survival is defined as time from start of AMR treatment in feeder study (16-HMedIdeS-12) to graft loss. Graft loss is defined as permanent return to dialysis for at least 6 weeks, re-transplantation, or nephrectomy. Data table show number of patients with a functioning graft at Year 3.
TERMINATED
18 participants
3 years after start of AMR treatment in feeder study (16-HMedIdeS-12)
2025-05-28
Participant Flow
Participant milestones
| Measure |
Imlifidase Treatment in Feeder Study 16-HMedIdeS-12
No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with imlifidase.
Imlifidase: Immunoglobulin G degrading enzyme of Streptococcus pyogenes
|
Plasma Exchange (PE) Treatment in Feeder Study 16-HMedIdeS-12
No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with PE.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
7
|
|
Overall Study
COMPLETED
|
3
|
1
|
|
Overall Study
NOT COMPLETED
|
8
|
6
|
Reasons for withdrawal
| Measure |
Imlifidase Treatment in Feeder Study 16-HMedIdeS-12
No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with imlifidase.
Imlifidase: Immunoglobulin G degrading enzyme of Streptococcus pyogenes
|
Plasma Exchange (PE) Treatment in Feeder Study 16-HMedIdeS-12
No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with PE.
|
|---|---|---|
|
Overall Study
Graft loss
|
2
|
1
|
|
Overall Study
Patient not eligible as no AMR in feeder trial
|
1
|
0
|
|
Overall Study
Study terminated by sponsor
|
5
|
3
|
|
Overall Study
Sponsor decision
|
0
|
2
|
Baseline Characteristics
An Long-term Follow-up Trial of Kidney Tx Patients Treated With Imlifidase or PE After an AMR
Baseline characteristics by cohort
| Measure |
Imlifidase Treatment in Feeder Study 16-HMedIdeS-12
n=11 Participants
No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with imlifidase.
Imlifidase: Immunoglobulin G degrading enzyme of Streptococcus pyogenes
|
Plasma Exchange (PE) Treatment in Feeder Study 16-HMedIdeS-12
n=7 Participants
No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with PE.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.9 years
STANDARD_DEVIATION 17.6 • n=5 Participants
|
48.0 years
STANDARD_DEVIATION 13.5 • n=7 Participants
|
46.7 years
STANDARD_DEVIATION 15.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
France
|
8 participants
n=5 Participants
|
2 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
BMI
|
27.1 kg/m^2
STANDARD_DEVIATION 6.9 • n=5 Participants
|
29.0 kg/m^2
STANDARD_DEVIATION 7.1 • n=7 Participants
|
27.8 kg/m^2
STANDARD_DEVIATION 6.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: 3 years after start of AMR treatment in feeder study (16-HMedIdeS-12)Population: Due to the premature termination of the trial, 7 patients in the Imlifidase treatment group and 6 patients in the Plasma exchange treatment group had no graft survival data for the 3 year timepoint
Graft survival is defined as time from start of AMR treatment in feeder study (16-HMedIdeS-12) to graft loss. Graft loss is defined as permanent return to dialysis for at least 6 weeks, re-transplantation, or nephrectomy. Data table show number of patients with a functioning graft at Year 3.
Outcome measures
| Measure |
Imlifidase Treatment in Feeder Study 16-HMedIdeS-12
n=11 Participants
No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with imlifidase.
Imlifidase: Immunoglobulin G degrading enzyme of Streptococcus pyogenes
|
Plasma Exchange (PE) Treatment in Feeder Study 16-HMedIdeS-12
n=7 Participants
No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with PE.
|
|---|---|---|
|
Overall Graft Survival at Year 3
Number of patients with a functioning graft
|
2 Participants
|
0 Participants
|
|
Overall Graft Survival at Year 3
Number of patients with graft loss
|
2 Participants
|
1 Participants
|
|
Overall Graft Survival at Year 3
Censored (patients being censored up to the time point)
|
7 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 2 years after start of AMR treatment in feeder study (16-HMedIdeS-12)Population: Due to the premature termination of the trial, 6 patients in the Imlifidase treatment group and 4 patients in the Plasma exchange treatment group have no graft survival data for Year 2.
Graft survival is defined as time from start of AMR treatment in feeder study (16-HMedIdeS-12) to graft loss. Graft loss is defined as permanent return to dialysis for at least 6 weeks, re-transplantation, or nephrectomy.
Outcome measures
| Measure |
Imlifidase Treatment in Feeder Study 16-HMedIdeS-12
n=11 Participants
No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with imlifidase.
Imlifidase: Immunoglobulin G degrading enzyme of Streptococcus pyogenes
|
Plasma Exchange (PE) Treatment in Feeder Study 16-HMedIdeS-12
n=7 Participants
No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with PE.
|
|---|---|---|
|
Overall Graft Survival at Year 2
Number of patients with a functioning graft
|
3 Participants
|
2 Participants
|
|
Overall Graft Survival at Year 2
Number of patients with graft loss
|
2 Participants
|
1 Participants
|
|
Overall Graft Survival at Year 2
Censored (patients being censored up to the time point)
|
6 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 1 year after start of AMR treatment in feeder study (16-HMedIdeS-12)Population: Due to the premature termination of the trial, 1 patient in each treatment group have no data for Year 1.
Graft survival is defined as time from start of AMR treatment in feeder study (16-HMedIdeS-12) to graft loss. Graft loss is defined as permanent return to dialysis for at least 6 weeks, re-transplantation, or nephrectomy.
Outcome measures
| Measure |
Imlifidase Treatment in Feeder Study 16-HMedIdeS-12
n=11 Participants
No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with imlifidase.
Imlifidase: Immunoglobulin G degrading enzyme of Streptococcus pyogenes
|
Plasma Exchange (PE) Treatment in Feeder Study 16-HMedIdeS-12
n=7 Participants
No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with PE.
|
|---|---|---|
|
Overall Graft Survival at Year 1
Number of patients with a functioning graft
|
8 Participants
|
5 Participants
|
|
Overall Graft Survival at Year 1
Number of patients with graft loss
|
2 Participants
|
1 Participants
|
|
Overall Graft Survival at Year 1
Censored (patients being censored up to the time point)
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 3 years after start of AMR treatment in feeder study (16-HMedIdeS-12)Population: Due to the premature termination of the trial, 9 patients in the Imlifidase treatment group and 7 patients in the Plasma exchange treatment group have no survival data for the 3 year timepoint.
Overall patient survival is defined as time from start of AMR treatment in feeder study (16-HMedIdeS-12) to death for any cause.
Outcome measures
| Measure |
Imlifidase Treatment in Feeder Study 16-HMedIdeS-12
n=11 Participants
No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with imlifidase.
Imlifidase: Immunoglobulin G degrading enzyme of Streptococcus pyogenes
|
Plasma Exchange (PE) Treatment in Feeder Study 16-HMedIdeS-12
n=7 Participants
No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with PE.
|
|---|---|---|
|
Patient Survival at Year 3
At risk (patients being at risk for event at the time point)
|
2 Participants
|
0 Participants
|
|
Patient Survival at Year 3
Event (patients having events up to the time point)
|
0 Participants
|
0 Participants
|
|
Patient Survival at Year 3
Censored (patients being censored up to the time point)
|
9 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 1, 2 and 3 years after start of AMR treatment in feeder study (16-HMedIdeS-12)Population: Due to the premature termination of the trial a large proportion of the patients did not complete the trial and no data were collected for Year 3 in the "Plasma exchange treatment in feeder Study 16-HMedIdeS-12" arm.
Estimated glomerular filtration rate (eGFR) was calculated as described by the Modification of Diet in Renal Disease Study (MDRD) equation. eGFR is a measure of kidney function. eGFR for a kidney with normal function is 90 mL/min/1.72m2. Kidney disease is characterised by a decreased eGFR value.
Outcome measures
| Measure |
Imlifidase Treatment in Feeder Study 16-HMedIdeS-12
n=11 Participants
No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with imlifidase.
Imlifidase: Immunoglobulin G degrading enzyme of Streptococcus pyogenes
|
Plasma Exchange (PE) Treatment in Feeder Study 16-HMedIdeS-12
n=7 Participants
No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with PE.
|
|---|---|---|
|
Kidney Function as Evaluated by eGFR
Year 1
|
30.1 mL/min/1.73 m^2
Standard Deviation 20.9
|
36.6 mL/min/1.73 m^2
Standard Deviation 12.3
|
|
Kidney Function as Evaluated by eGFR
Year 2
|
41.2 mL/min/1.73 m^2
Standard Deviation 6.4
|
39.7 mL/min/1.73 m^2
|
|
Kidney Function as Evaluated by eGFR
Year 3
|
30.5 mL/min/1.73 m^2
|
—
|
SECONDARY outcome
Timeframe: 1, 2 and 3 years after start of AMR treatment in feeder study (16-HMedIdeS-12)Population: Due to premature termination of the trial by the Sponsor, only very few patients had assessments at Year 2 and Year 3 and no data were collected for Year 3 in the "Plasma exchange treatment in feeder Study 16-HMedIdeS-12" arm.
S/P-creatinine is a measure of kidney function. Kidney disease is characterized by an increased S/P-creatinine level.
Outcome measures
| Measure |
Imlifidase Treatment in Feeder Study 16-HMedIdeS-12
n=11 Participants
No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with imlifidase.
Imlifidase: Immunoglobulin G degrading enzyme of Streptococcus pyogenes
|
Plasma Exchange (PE) Treatment in Feeder Study 16-HMedIdeS-12
n=7 Participants
No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with PE.
|
|---|---|---|
|
Kidney Function as Evaluated by S/P-creatinine
Year 1
|
297 umol/L
Interval 81.0 to 795.0
|
187 umol/L
Interval 102.0 to 288.0
|
|
Kidney Function as Evaluated by S/P-creatinine
Year 2
|
130 umol/L
Interval 107.0 to 161.0
|
187 umol/L
|
|
Kidney Function as Evaluated by S/P-creatinine
Year 3
|
144 umol/L
|
—
|
SECONDARY outcome
Timeframe: 3 years after start of AMR treatment in feeder study (16-HMedIdeS-12)Information about rejection episodes will be collected, according to Banff 2017 or later classification. For-cause biopsies together with contemporaneous local DSA analyses, kidney function parameters (creatinine, albumin/creatinine ratio in urine) and treatments (e.g. plasma exchange and IVIg) will be collected to assess the rejection episodes.
Outcome measures
| Measure |
Imlifidase Treatment in Feeder Study 16-HMedIdeS-12
n=11 Participants
No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with imlifidase.
Imlifidase: Immunoglobulin G degrading enzyme of Streptococcus pyogenes
|
Plasma Exchange (PE) Treatment in Feeder Study 16-HMedIdeS-12
n=7 Participants
No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with PE.
|
|---|---|---|
|
Number of Participants With Presumed or Biopsy Proven AMR Episodes
|
9 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 3 years after start of AMR treatment in feeder study (16-HMedIdeS-12)Information about rejection episodes will be collected, according to Banff 2017 or later classification. For-cause biopsies together with contemporaneous local DSA analyses, kidney function parameters (creatinine, albumin/creatinine ratio in urine) and treatments (e.g. plasma exchange and IVIg) will be collected to assess the rejection episodes.
Outcome measures
| Measure |
Imlifidase Treatment in Feeder Study 16-HMedIdeS-12
n=11 Participants
No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with imlifidase.
Imlifidase: Immunoglobulin G degrading enzyme of Streptococcus pyogenes
|
Plasma Exchange (PE) Treatment in Feeder Study 16-HMedIdeS-12
n=7 Participants
No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with PE.
|
|---|---|---|
|
Number of Participants With Presumed or Biopsy-proven Rejection Episodes (Other Than AMR Episodes)
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 1, 2 and 3 years after start of AMR treatment in feeder study (16-HMedIdeS-12)Population: Due to premature termination of the trial by the Sponsor, some patients have no DSA assessments done at Year 1, Year 2 and Year 3 and no data were collected for Year 3 in the "Plasma exchange treatment in feeder Study 16-HMedIdeS-12" arm.
DSA levels will be measured using single antigen bead human leukocyte antigen (SAB-HLA) assay
Outcome measures
| Measure |
Imlifidase Treatment in Feeder Study 16-HMedIdeS-12
n=11 Participants
No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with imlifidase.
Imlifidase: Immunoglobulin G degrading enzyme of Streptococcus pyogenes
|
Plasma Exchange (PE) Treatment in Feeder Study 16-HMedIdeS-12
n=7 Participants
No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with PE.
|
|---|---|---|
|
DSA Levels
Visit 2 - feeder trial pre-treatment
|
10764 Mean Fluorescence Intensity
Standard Deviation 7603
|
15794 Mean Fluorescence Intensity
Standard Deviation 5897
|
|
DSA Levels
1 year post dosing
|
5964 Mean Fluorescence Intensity
Standard Deviation 5539
|
3672 Mean Fluorescence Intensity
Standard Deviation 643
|
|
DSA Levels
2 years post dosing
|
2156 Mean Fluorescence Intensity
Standard Deviation 1025
|
12362 Mean Fluorescence Intensity
|
|
DSA Levels
3 years post dosing
|
974 Mean Fluorescence Intensity
|
—
|
SECONDARY outcome
Timeframe: 1,2 and 3 years after start of AMR treatment in feeder study (16-HMedIdeS-12)Population: Only patients exposed to imlifidase were assessed for anti-imlifidase antibodies (ADA). Due to premature termination of the trial by the Sponsor, some imlifidase treated patients have no ADA assessments done at Year 1, Year 2 and Year 3
The immunogenicity of imlifidase will be assessed by measuring ADA levels.
Outcome measures
| Measure |
Imlifidase Treatment in Feeder Study 16-HMedIdeS-12
n=11 Participants
No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with imlifidase.
Imlifidase: Immunoglobulin G degrading enzyme of Streptococcus pyogenes
|
Plasma Exchange (PE) Treatment in Feeder Study 16-HMedIdeS-12
No treatment is given in this long-term follow-up study. In the feeder study (16-HMedIdeS-12) the patients in this group were treated with PE.
|
|---|---|---|
|
ADA Levels
1 year post dosing
|
75 mg/L
Geometric Coefficient of Variation 405
|
—
|
|
ADA Levels
2 years post dosing
|
41 mg/L
Geometric Coefficient of Variation 1426
|
—
|
|
ADA Levels
3 years post dosing
|
15 mg/L
|
—
|
Adverse Events
Imlifidase Treatment in Feeder Study 16-HMedIdeS-12
Plasma Exchange (PE) Treatment in Feeder Study 16-HMedIdeS-12
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Vice President Research and Development
Hansa Biopharma AB
Results disclosure agreements
- Principal investigator is a sponsor employee At the end of the study, one or more manuscripts for joint publication may be prepared in collaboration between the investigator(s) offered authorship and Hansa Biopharma. Any confidential information relating to imlifidase or the study, including any data and results from the study will be the exclusive property of Hansa Biopharma AB. The investigators and any other persons involved in the trial will protect the confidentiality of the proprietary information belonging to Hansa Biopharma AB
- Publication restrictions are in place
Restriction type: OTHER