Trial · NCT03897205

An Efficacy and Safety Study of Imlifidase in Treatment of Antibody-Mediated Rejection in Kidney Transplant Patients

NCT03897205, Phase 2, Completed, Hansa Biopharma AB; results first posted 2024-02-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. An Efficacy and Safety Study of Imlifidase in Treatment of Antibody-Mediated Rejection in Kidney Transplant Patients. Trials, record NCT03897205. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03897205

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: An Efficacy and Safety Study of Imlifidase in Treatment of Antibody-Mediated Rejection in Kidney Transplant Patients
NCT number: NCT03897205
Status: Completed
Phases: Phase 2
Enrollment: 30 participants, actual
Lead sponsor: Hansa Biopharma AB
Conditions: Kidney Transplant Rejection
Interventions: Imlifidase, Plasma Exchange
First posted: 2019-04-01
Last updated: 2024-02-28
Other registries' IDs: eudract:2018-000022-66
Results first posted: 2024-02-28

Source ClinicalTrials.gov

Registered outcomes19

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Maximum Reduction in Donor Specific Antibodies (DSA) Level During the 5 Days Following the Start of Treatment	Start of treatment until 5 days following start of treatment	Maximum reduction (%) in the sum of DSA at any time point during the 5 days following the start of treatment. Only DSA with ≥1000 mean fluorescence intensity (MFI) at pre-treatment were included in the calculations. Clarification: The higher the maximum reduction percentage the lower the remaining DSA level.
Secondary	Reduction in DSA Levels After Treatment	Screening until Day 180	DSA levels were assessed at all visits throughout the study. The results are presented as reduction (%) from baseline. Clarification: The higher the reduction percentage the lower the remaining DSA level. Please observe that a negative reduction value represents an increase in DSA level from baseline.
Secondary	Estimated Glomerular Filtration Rate (eGFR) Levels	Screening until Day 180	eGFR as calculated from p-creatinine is a measure of kidney function. eGFR was assessed at all visits throughout the study.
Secondary	Urine Albumine/Creatinine Ratio	Pre-dose until Day 180	The albumine/creatinine ratio in urine is a measure of kidney function.
Secondary	Number of Patients With Graft Loss Within 180 Days of Treatment	Screening until Day 180	Information on patients who experienced graft loss was collected throughout the study.
Secondary	Number of Patients With Signs or no Signs of Transplant Glomerulopathy at Day 180	Day 180	Biopsies collected 180 days after treatment were analysed for signs of glomerulopathy.
Secondary	Number of Patients With Different Types of Kidney Histopathology Throughout the Trial	Screening, Day 29 and Day 180	Kidney biopsies were assessed according to the Banff (2017) criteria at screening (baseline), Day 29, and Day 180. Abbreviations: AMR=Antibody mediated rejection, CMR=cell-mediated rejection
Secondary	Number of Patients With Resolved AMR as Assessed by Messenger Ribonucleic Acid (mRNA) Levels	Screening, Day 29, and Day 180	Kidney biopsies were taken at screening, Day 29, and Day 180. Changes from baseline in mRNA levels were assessed as evidence of resolved AMR.
Secondary	Number of Administered Plasma Exchange (PE) and Immunoadsorption (IA) Sessions	Day 1 to Day 180	Total number of administered PE and IA sessions to each treatment group are presented during the complete trial (Day 1 to Day 180) and for the time period: start of IVIg administration to Day 180.
Secondary	Total Serum Immunoglobulin G (IgG) Levels Until Administration of Intravenous Immunoglobulin (IVIg)	Pre-dose until Day 6	Total serum IgG levels over time following treatment until administration of IVIg. Please observe, IVIg was initiated on Day 4 (before 96 h measurement) for the imlifidase group.

1 to 10 of 19Source ClinicalTrials.gov

See all 19 registered outcomes

Outcomes19

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Maximum Reduction in Donor Specific Antibodies (DSA) Level During the 5 Days Following the Start of Treatment	Start of treatment until 5 days following start of treatment	Participants with MFI values less than 1000 were excluded from the analysis	percentage of maximum DSA reduction	MEAN
SECONDARY	Reduction in DSA Levels After Treatment	Screening until Day 180		percentage of DSA reduction	MEAN
SECONDARY	Estimated Glomerular Filtration Rate (eGFR) Levels	Screening until Day 180	Some patients had missing values at sporadic occasions.	mL/min/1.73m2	MEAN
SECONDARY	Urine Albumine/Creatinine Ratio	Pre-dose until Day 180	Some patients had missing data at different occasions during the study.	mg/g	MEAN
SECONDARY	Number of Patients With Graft Loss Within 180 Days of Treatment	Screening until Day 180		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Patients With Signs or no Signs of Transplant Glomerulopathy at Day 180	Day 180		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Patients With Different Types of Kidney Histopathology Throughout the Trial	Screening, Day 29 and Day 180		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Patients With Resolved AMR as Assessed by Messenger Ribonucleic Acid (mRNA) Levels	Screening, Day 29, and Day 180		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Administered Plasma Exchange (PE) and Immunoadsorption (IA) Sessions	Day 1 to Day 180	In total 4 patients from the imlifidase arm were treated with PE. Of these 3 patients received PE after start of IVIg.~All 10 patients from the PE arm were treated with PE. Of these 1 patient received PE after start of IVIg.~One (1) patient from the PE arm also received IA after start of IVIg.	Sessions	NUMBER
SECONDARY	Total Serum Immunoglobulin G (IgG) Levels Until Administration of Intravenous Immunoglobulin (IVIg)	Pre-dose until Day 6		mg/mL	MEAN

1 to 10 of 19Source ClinicalTrials.gov

See all 19 outcomes

Results by group318

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Maximum Reduction in Donor Specific Antibodies (DSA) Level During the 5 Days Following the Start of Treatment	Imlifidase		94	Standard Deviation 4	percentage of maximum DSA reduction
Maximum Reduction in Donor Specific Antibodies (DSA) Level During the 5 Days Following the Start of Treatment	Plasma Exchange		36	Standard Deviation 26	percentage of maximum DSA reduction
Reduction in DSA Levels After Treatment	Imlifidase	2 hours	91	Standard Deviation 7	percentage of DSA reduction
Reduction in DSA Levels After Treatment	Plasma Exchange	2 hours	-2	Standard Deviation 28	percentage of DSA reduction
Reduction in DSA Levels After Treatment	Imlifidase	6 hours	94	Standard Deviation 4	percentage of DSA reduction
Reduction in DSA Levels After Treatment	Plasma Exchange	6 hours	-2	Standard Deviation 33	percentage of DSA reduction
Reduction in DSA Levels After Treatment	Imlifidase	24 hours	92	Standard Deviation 5	percentage of DSA reduction
Reduction in DSA Levels After Treatment	Plasma Exchange	24 hours	0	Standard Deviation 25	percentage of DSA reduction
Reduction in DSA Levels After Treatment	Imlifidase	48 hours	89	Standard Deviation 10	percentage of DSA reduction
Reduction in DSA Levels After Treatment	Plasma Exchange	48 hours	18	Standard Deviation 34	percentage of DSA reduction

1 to 10 of 318Source ClinicalTrials.gov

See all 318 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Imlifidase	19
Overall Study	STARTED	Plasma Exchange	10
Overall Study	COMPLETED	Imlifidase	17
Overall Study	COMPLETED	Plasma Exchange	10
Overall Study	NOT COMPLETED	Imlifidase	2
Overall Study	NOT COMPLETED	Plasma Exchange	0

Source ClinicalTrials.gov

Adverse events174

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anaemia	Blood and lymphatic system disorders	Imlifidase	2	19	2
other	Anaemia	Blood and lymphatic system disorders	Plasma Exchange	0	10	0
other	Leukocytosis	Blood and lymphatic system disorders	Imlifidase	1	19	1
other	Leukocytosis	Blood and lymphatic system disorders	Plasma Exchange	0	10	0
other	Leukopenia	Blood and lymphatic system disorders	Imlifidase	1	19	1
other	Leukopenia	Blood and lymphatic system disorders	Plasma Exchange	1	10	1
other	Lymphopenia	Blood and lymphatic system disorders	Imlifidase	1	19	1
other	Lymphopenia	Blood and lymphatic system disorders	Plasma Exchange	0	10	0
other	Thrombocytopenia	Blood and lymphatic system disorders	Imlifidase	4	19	5
other	Thrombocytopenia	Blood and lymphatic system disorders	Plasma Exchange	1	10	1

1 to 10 of 174Source ClinicalTrials.gov

See all 174 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Imlifidase	1	19
Total, all-cause mortality	Plasma Exchange	0	10
Total, other adverse events	Imlifidase	17	19
Total, other adverse events	Plasma Exchange	10	10
Total, serious adverse events	Imlifidase	3	19
Total, serious adverse events	Plasma Exchange	3	10

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
39023092	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Imlifidase vs Plasma Exchange: Number of Patients With Graft Loss Within 180 Days of Treatment	Trial comparisons
Imlifidase vs Plasma Exchange: deaths from any cause	Trial comparisons
Imlifidase vs Plasma Exchange: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03897205

GET https://conductscience.org/api/trials/v1/NCT03897205/results?page=2

API reference For AI assistants