Trial · NCT03157037
Open-Label Phase II Study to Evaluate the Efficacy and Safety of IdeS in Anti-GBM Disease
NCT03157037, Phase 2, Completed, Mårten Segelmark; results first posted 2022-04-07
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Open-Label Phase II Study to Evaluate the Efficacy and Safety of IdeS in Anti-GBM Disease. Trials, record NCT03157037. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03157037
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-Label Phase II Study to Evaluate the Efficacy and Safety of IdeS in Anti-GBM Disease
- NCT number
- NCT03157037
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 15 participants, actual
- Lead sponsor
- Mårten Segelmark
- Conditions
- Anti-Glomerular Basement Membrane Antibody Disease
- Interventions
- Imlifidase
- First posted
- 2017-05-17
- Last updated
- 2022-04-07
- Results first posted
- 2022-04-07
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Independent Renal Function at 6 Months | 6 months after dosing | Number of patients without need for dialysis at 6 months. A patient with independent renal function is defined as a patient without need for dialysis. |
| Secondary | Number of Patients With Independent Renal Function at 3 Months | 3 months after dosing | Number of patients without need for dialysis at 3 months. A patient with independent renal function is defined as a patient without need for dialysis. |
| Secondary | Renal Function at 3 and 6 Months | 3 and 6 months after imlifidase dosing | Estimated glomerular filtration rate (eGFR) is a measure of kidney function. eGFR was calculated based on p-creatinine according to the modification of diet in renal disease (MDRD) equation. eGFR for a kidney with normal function is above 90 mL/min/1.73m\^2. Reduced kidney function is characterised by a decreased eGFR value. |
| Secondary | Number of Patients With Renal Function Over Time Stratified by Ranges of eGFR | Pre-imlifidase, 1, 3 and 6 months after imlifidase dosing | eGFR is a measure of kidney function. eGFR has been calculated based on p-creatinine according to the modification of diet in renal disease (MDRD) equation. eGFR for a kidney with normal function is above 90 mL/min/1.73m\^2. Reduced kidney function is characterised by a decreased eGFR value. Number of patients per 4 different eGFR categories (0-15, 15-30, 30-60, ≥60 mL/min/1.73m\^2) are presented. A shift towards a higher category during the study indicates improved renal function over time. |
| Secondary | Number of Patients With Anti-GBM Antibodies Above a Toxic Level Stratified by Number of Study Visits | Predose up to 6 months after dosing | Anti-GBM antibodies above a toxic level defined as \>20 U/mL. The level of anti-GBM antibodies was measured centrally using the Phadia ELiA(TM) anti-GBM kit. The enzyme-linked immunoassay (ELiA) is a fluorescence enzyme immunoassay. |
| Secondary | Number of Patients With Haematuria (Blood in Urine) | At 6 months after dosing | Haematuria was assessed using urine dipstick. The result was presented as: Negative/Trace/+1/+2/+3/+4. In the analysis results being +2 or above are considered as relevant. Haematuria was an inclusion criterion. All 15 patients had haematuria when included in the study. |
| Secondary | Change in Proteinuria During the Study | Pre-imlifidase, 3 and 6 months after imlifidase dosing | Change in proteinuria measured as u-albumin/creatinine (g/mol) in morning void during the study . |
| Secondary | Number of PLEXs Needed Over Time | Pre-screening and up to Day 93 after imlifidase dosing | Number of PLEXs needed before anti-GBM antibodies are below toxic levels. PLEX was initiated at the discretion of the investigator throughout the study. |
| Secondary | Pharmacokinetics of Imlifidase (Cmax) | Pre-dose, 45min, 2h, 6h, 24h, Day3, Day 7, Day 10, and Day15 | Maximum observed plasma concentration of IdeS following dosing (Cmax) |
| Secondary | Pharmacokinetics of Imlifidase (AUC) | Pre-dose, 45min, 2h, 6h, 24h, Day3, Day 7, Day 10, and Day15 | Area under the plasma concentration versus time curve (AUC) |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With Independent Renal Function at 6 Months | 6 months after dosing | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Patients With Independent Renal Function at 3 Months | 3 months after dosing | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Renal Function at 3 and 6 Months | 3 and 6 months after imlifidase dosing | Only patients who were alive and dialysis independent at respective analysis time (3 and 6 months) were included in this analysis because assessment of eGFR is not considered meaningful for patients in dialysis. | mL/min/1.73m^2 | MEAN |
| SECONDARY | Number of Patients With Renal Function Over Time Stratified by Ranges of eGFR | Pre-imlifidase, 1, 3 and 6 months after imlifidase dosing | Only patients who were alive and dialysis independent at each specific analysis time are included in this analysis because eGFR is not applicable for patients in dialysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With Anti-GBM Antibodies Above a Toxic Level Stratified by Number of Study Visits | Predose up to 6 months after dosing | Number of study visits with a toxic level are presented instead of number of patient days with an anti-GBM level \>20 U/mL as was the original plan. | participants | NUMBER |
| SECONDARY | Number of Patients With Haematuria (Blood in Urine) | At 6 months after dosing | Data was missing for 5 of the 15 patients at 6 months. | Patients with haematuria (+2 or above) | NUMBER |
| SECONDARY | Change in Proteinuria During the Study | Pre-imlifidase, 3 and 6 months after imlifidase dosing | Some patients had missing data at some visits | g/mol | MEAN |
| SECONDARY | Number of PLEXs Needed Over Time | Pre-screening and up to Day 93 after imlifidase dosing | Number of PLEX performed | NUMBER | |
| SECONDARY | Pharmacokinetics of Imlifidase (Cmax) | Pre-dose, 45min, 2h, 6h, 24h, Day3, Day 7, Day 10, and Day15 | µg/mL | GEOMETRIC_MEAN | |
| SECONDARY | Pharmacokinetics of Imlifidase (AUC) | Pre-dose, 45min, 2h, 6h, 24h, Day3, Day 7, Day 10, and Day15 | h*µg/mL | GEOMETRIC_MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group157
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With Independent Renal Function at 6 Months | Dialysis Dependent at Baseline | 5 | Participants | ||
| Number of Patients With Independent Renal Function at 6 Months | Dialysis Independent at Baseline | 5 | Participants | ||
| Number of Patients With Independent Renal Function at 6 Months | All Patients | 10 | Participants | ||
| Number of Patients With Independent Renal Function at 3 Months | Dialysis Dependent at Baseline | 4 | Participants | ||
| Number of Patients With Independent Renal Function at 3 Months | Dialysis Independent at Baseline | 5 | Participants | ||
| Number of Patients With Independent Renal Function at 3 Months | All Patients | 9 | Participants | ||
| Renal Function at 3 and 6 Months | Dialysis Dependent at Baseline | eGFR at 3 months | 20.3 | Standard Deviation 4.7 | mL/min/1.73m^2 |
| Renal Function at 3 and 6 Months | Dialysis Independent at Baseline | eGFR at 3 months | 26.5 | Standard Deviation 11.0 | mL/min/1.73m^2 |
| Renal Function at 3 and 6 Months | All Patients | eGFR at 3 months | 23.8 | Standard Deviation 8.9 | mL/min/1.73m^2 |
| Renal Function at 3 and 6 Months | Dialysis Dependent at Baseline | eGFR at 6 months | 24.8 | Standard Deviation 6.6 | mL/min/1.73m^2 |
1 to 10 of 157Source ClinicalTrials.gov
See all 157 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment HMed-IdeS | 15 | |
| Overall Study | COMPLETED | Treatment HMed-IdeS | 14 | |
| Overall Study | NOT COMPLETED | Treatment HMed-IdeS | 1 |
Source ClinicalTrials.gov
Adverse events70
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 | Safety Analysis Set | 6 | 15 | 6 |
| other | Tinnitus | Ear and labyrinth disorders | Safety Analysis Set | 2 | 15 | 3 |
| other | Foreign body sensation in eyes | Eye disorders | Safety Analysis Set | 1 | 15 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Safety Analysis Set | 2 | 15 | 2 |
| other | Nausea | Gastrointestinal disorders | Safety Analysis Set | 4 | 15 | 4 |
| other | Vomiting | Gastrointestinal disorders | Safety Analysis Set | 2 | 15 | 2 |
| other | Fatigue | General disorders | Safety Analysis Set | 1 | 15 | 1 |
| other | Cryoglobulinaemia | Immune system disorders | Safety Analysis Set | 1 | 15 | 1 |
| other | Hypogammaglobulinaemia | Immune system disorders | Safety Analysis Set | 1 | 15 | 1 |
| other | Clostridium difficile infection | Infections and infestations | Safety Analysis Set | 1 | 15 | 1 |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Safety Analysis Set | 1 | 15 |
| Total, other adverse events | Safety Analysis Set | 15 | 15 |
| Total, serious adverse events | Safety Analysis Set | 5 | 15 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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/NCT03157037
GET https://conductscience.org/api/trials/v1/NCT03157037/results?page=2