Open-Label Phase II Study to Evaluate the Efficacy and Safety of IdeS in Anti-GBM Disease (GOOD-IDES-01)

• ClinicalTrials.gov Identifier: NCT03157037
• Recruitment Status: Completed
• First Posted: May 17, 2017
• Results First Posted: April 7, 2022
• Last Update Posted: April 7, 2022
• Sponsor: Mårten Segelmark
• Collaborator: Hansa Biopharma AB
• Information provided by (Responsible Party): Mårten Segelmark, Linkoeping University

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Anti-Glomerular Basement Membrane Antibody Disease
• Intervention: Biological: Imlifidase
• Enrollment: 15

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Treatment HMed-IdeS
Arm/Group Description	A single dose of IdeS (imlifidase) 0.25 mg/kg body weight (BW) intravenous infusion on study Day 1
Period Title: Overall Study
Started	15
Completed	14
Not Completed	1
Reason Not Completed
Death	1

Baseline Characteristics

Arm/Group Title		Imlifidase
Arm/Group Description		IdeS intravenous infusion 0.25 mg/kg body weight (BW) intravenous infusion HMed-IdeS: One dose of 0.25 mg/kg BW HMed-IdeS on study day 1
Overall Number of Baseline Participants		15
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Median (Full Range); Unit of measure: Years
	Number Analyzed	15 participants
		61; (19 to 77)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	15 participants
	Female	6 40.0%
	Male	9 60.0%
Race and Ethnicity Not Collected [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	0 participants
		[1] Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
Sweden	Number Analyzed	15 participants
		4
Austria	Number Analyzed	15 participants
		2
Czechia	Number Analyzed	15 participants
		1
Denmark	Number Analyzed	15 participants
		3
France	Number Analyzed	15 participants
		5
Dialysis status at baseline; Measure Type: Count of Participants; Unit of measure: Participants
Dialysis	Number Analyzed	15 participants
		10 66.7%
Not on dialysis but eGFR <15 mL/min/1.73 m^2	Number Analyzed	15 participants
		5 33.3%
Time since anti-glomerular basement membrane (anti-GBM) diagnosis; Median (Full Range); Unit of measure: Days
	Number Analyzed	15 participants
		2; (0 to 40)
Anti-GBM concentration; Median (Full Range); Unit of measure: U/mL
	Number Analyzed	15 participants
		130; (2 to 1090)
Time since first renal symptom; Median (Full Range); Unit of measure: Days
	Number Analyzed	15 participants
		10; (4 to 76)
Occurrence of pulmonary symptom; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	15 participants
	Yes	9 60.0%
	No	3 20.0%
	Not reported	3 20.0%
Time since first pulmonary symptom; Median (Full Range); Unit of measure: Days
	Number Analyzed	15 participants
		32; (1 to 113)
Double positive Anti-GBM and antineutrophil cytoplasmic antibodies (ANCA) [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	15 participants
	Yes	6 40.0%
	No	9 60.0%
		[1] Measure Description: ANCA=anti-neutrophil cytoplasm antibody

Outcome Measures

1. Primary Outcome

Title	Number of Patients With Independent Renal Function at 6 Months
Description	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.
Time Frame	6 months after dosing

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dialysis Dependent at Baseline	Dialysis Independent at Baseline	All Patients
Arm/Group Description:	Patients who were dialysis dependent at baseline	Patients who were dialysis independent at baseline	All patients (i.e., both patients who were dialysis dependent and patients who were dialysis independent at baseline)
Overall Number of Participants Analyzed	10	5	15
Measure Type: Count of Participants; Unit of Measure: Participants
	5 50.0%	5 100.0%	10 66.7%

2. Secondary Outcome

Title	Number of Patients With Independent Renal Function at 3 Months
Description	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.
Time Frame	3 months after dosing

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dialysis Dependent at Baseline	Dialysis Independent at Baseline	All Patients
Arm/Group Description:	Patients who were dialysis dependent at baseline	Patients who were dialysis independent at baseline	All patients (i.e., both patients who were dialysis dependent and patients who were dialysis independent at baseline)
Overall Number of Participants Analyzed	10	5	15
Measure Type: Count of Participants; Unit of Measure: Participants
	4 40.0%	5 100.0%	9 60.0%

3. Secondary Outcome

Title	Renal Function at 3 and 6 Months
Description	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.
Time Frame	3 and 6 months after imlifidase dosing

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title		Dialysis Dependent at Baseline	Dialysis Independent at Baseline	All Patients
Arm/Group Description:		Patients who were dialysis dependent at baseline	Patients who were dialysis independent at baseline	All patients (i.e., both patients who were dialysis dependent and patients who were dialysis independent at baseline)
Overall Number of Participants Analyzed		5	5	10
Mean (Standard Deviation); Unit of Measure: mL/min/1.73m^2
eGFR at 3 months	Number Analyzed	3 participants	4 participants	7 participants
		20.3 (4.7)	26.5 (11.0)	23.8 (8.9)
eGFR at 6 months	Number Analyzed	5 participants	5 participants	10 participants
		24.8 (6.6)	36.9 (17.3)	30.9 (13.9)

4. Secondary Outcome

Title	Number of Patients With Renal Function Over Time Stratified by Ranges of eGFR
Description	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.
Time Frame	Pre-imlifidase, 1, 3 and 6 months after imlifidase dosing

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title		Dialysis Dependent at Baseline	Dialysis Independent at Baseline	All Patients
Arm/Group Description:		Patients who were dialysis dependent at baseline	Patients who were dialysis independent at baseline	All patients (i.e., both patients who were dialysis dependent and patients who were dialysis independent at baseline)
Overall Number of Participants Analyzed		5	5	10
Measure Type: Count of Participants; Unit of Measure: Participants
Pre-imlifidase	Number Analyzed	1 participants	5 participants	6 participants
	eGFR (0-15)	1 100.0%	5 100.0%	6 100.0%
	eGFR (15-30)	0 0.0%	0 0.0%	0 0.0%
	eGFR (30-60)	0 0.0%	0 0.0%	0 0.0%
	eGFR (≥60)	0 0.0%	0 0.0%	0 0.0%
Month 1	Number Analyzed	2 participants	5 participants	7 participants
	eGFR (0-15)	1 50.0%	1 20.0%	2 28.6%
	eGFR (15-30)	1 50.0%	2 40.0%	3 42.9%
	eGFR (30-60)	0 0.0%	2 40.0%	2 28.6%
	eGFR (≥60)	0 0.0%	0 0.0%	0 0.0%
Month 3	Number Analyzed	3 participants	4 participants	7 participants
	eGFR (0-15)	0 0.0%	0 0.0%	0 0.0%
	eGFR (15-30)	3 100.0%	3 75.0%	6 85.7%
	eGFR (30-60)	0 0.0%	1 25.0%	1 14.3%
	eGFR (≥60)	0 0.0%	0 0.0%	0 0.0%
Month 6	Number Analyzed	5 participants	5 participants	10 participants
	eGFR (0-15)	0 0.0%	0 0.0%	0 0.0%
	eGFR (15-30)	4 80.0%	2 40.0%	6 60.0%
	eGFR (30-60)	1 20.0%	3 60.0%	4 40.0%
	eGFR (≥60)	0 0.0%	0 0.0%	0 0.0%

5. Secondary Outcome

Title	Number of Patients With Anti-GBM Antibodies Above a Toxic Level Stratified by Number of Study Visits
Description	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.
Time Frame	Predose up to 6 months after dosing

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Dialysis Dependent at Baseline	Dialysis Independent at Baseline	All Patients
Arm/Group Description:	Patients who were dialysis dependent at baseline	Patients who were dialysis independent at baseline	All patients (i.e., both patients who were dialysis dependent and patients who were dialysis independent at baseline)
Overall Number of Participants Analyzed	10	5	15
Measure Type: Number; Unit of Measure: participants
0 visits	1	1	2
1 visit	3	4	7
2 visits	1	0	1
3 visits	1	0	1
5 visits	2	0	2
6 visits	1	0	1
9 visits	1	0	1

6. Secondary Outcome

Title	Number of Patients With Haematuria (Blood in Urine)
Description	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.
Time Frame	At 6 months after dosing

Outcome Measure Data

Analysis Population Description

Data was missing for 5 of the 15 patients at 6 months.

Arm/Group Title	All Patients
Arm/Group Description:	All patients (i.e., both patients who were dialysis dependent and patients who were dialysis independent at baseline)
Overall Number of Participants Analyzed	10
Measure Type: Number; Unit of Measure: Patients with haematuria (+2 or above)
	3

7. Secondary Outcome

Title	Change in Proteinuria During the Study
Description	Change in proteinuria measured as u-albumin/creatinine (g/mol) in morning void during the study .
Time Frame	Pre-imlifidase, 3 and 6 months after imlifidase dosing

Outcome Measure Data

Analysis Population Description

Some patients had missing data at some visits

Arm/Group Title		Dialysis Dependent at Baseline	Dialysis Independent at Baseline	All Patients
Arm/Group Description:		Patients who were dialysis dependent at baseline	Patients who were dialysis independent at baseline	All patients irrespective of dialysis dependency at baseline and at 6 months
Overall Number of Participants Analyzed		10	5	15
Mean (Standard Deviation); Unit of Measure: g/mol
Pre-imlifidase	Number Analyzed	6 participants	5 participants	11 participants
		1117 (1544)	199 (166)	700 (1197)
3 months	Number Analyzed	5 participants	4 participants	9 participants
		220 (197)	153 (172)	190 (178)
6 months	Number Analyzed	9 participants	5 participants	14 participants
		183 (231)	122 (133)	161 (198)

8. Secondary Outcome

Title	Number of PLEXs Needed Over Time
Description	Number of PLEXs needed before anti-GBM antibodies are below toxic levels. PLEX was initiated at the discretion of the investigator throughout the study.
Time Frame	Pre-screening and up to Day 93 after imlifidase dosing

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dialysis Dependent at Baseline	Dialysis Independent at Baseline	All Patients
Arm/Group Description:	Patients who were dialysis dependent at baseline	Patients who were dialysis independent at baseline	All patients irrespective of dialysis dependency at baseline
Overall Number of Participants Analyzed	10	5	15
Measure Type: Number; Unit of Measure: Number of PLEX performed
Pre-Screening	10	23	33
Post-Screening to pre-imlifidase dose	5	0	5
Pre-imlifidase to Day 3	0	1	1
Day 3 to Day 7	8	0	8
Day 7 to Day 10	14	0	14
Day 10 to Day 15	20	2	22
Day 15 to Day 22	18	5	23
Day 22 to Day 29	5	1	6
Day 29 to Day 50	5	3	8
Day 50 to Day 93	0	1	1
Total (post-imlifidase to Day 93)	70	13	83
Total (pre-screening to Day 93)	85	36	121

9. Secondary Outcome

Title	Pharmacokinetics of Imlifidase (Cmax)
Description	Maximum observed plasma concentration of IdeS following dosing (Cmax)
Time Frame	Pre-dose, 45min, 2h, 6h, 24h, Day3, Day 7, Day 10, and Day15

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Patients
Arm/Group Description:	All patients (i.e., both patients who were dialysis dependent and patients who were dialysis independent at baseline)
Overall Number of Participants Analyzed	15
Geometric Mean (Full Range); Unit of Measure: µg/mL
	4.7; (2.6 to 8.0)

10. Secondary Outcome

Title	Pharmacokinetics of Imlifidase (AUC)
Description	Area under the plasma concentration versus time curve (AUC)
Time Frame	Pre-dose, 45min, 2h, 6h, 24h, Day3, Day 7, Day 10, and Day15

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Patients
Arm/Group Description:	All patients (i.e., both patients who were dialysis dependent and patients who were dialysis independent at baseline)
Overall Number of Participants Analyzed	15
Geometric Mean (Full Range); Unit of Measure: h*µg/mL
	158; (73 to 304)

11. Secondary Outcome

Title	Pharmacokinetics of Imlifidase (t1/2)
Description	Half-life during distribution phase (Alpha-t1/2) Half-life during elimination phase (Beta-t1/2) The results refers to harmonic mean.
Time Frame	Pre-dose, 45min, 2h, 6h, 24h, Day3, Day 7, Day 10, and Day15

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Patients
Arm/Group Description:	All patients (i.e., both patients who were dialysis dependent and patients who were dialysis independent at baseline)
Overall Number of Participants Analyzed	15
Mean (Full Range); Unit of Measure: h
Alpha-t1/2	2.6; (0.9 to 7.5)
Beta-t1/2	53; (26 to 115)

12. Secondary Outcome

Title	Pharmacokinetics of Imlifidase (CL)
Description	Clearance (CL) is a measure of the ability of the body to clear imlifidase from plasma
Time Frame	Pre-dose, 45min, 2h, 6h, 24h, Day3, Day 7, Day 10, and Day15

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Patients
Arm/Group Description:	All patients (i.e., both patients who were dialysis dependent and patients who were dialysis independent at baseline)
Overall Number of Participants Analyzed	15
Geometric Mean (Full Range); Unit of Measure: mL/h/kg
	1.6; (0.8 to 3.4)

13. Secondary Outcome

Title	Pharmacokinetics of Imlifidase (Vz)
Description	Vz = Volume of distribution during the elimination phase
Time Frame	Pre-dose, 45min, 2h, 6h, 24h, Day3, Day 7, Day 10, and Day15

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Patients
Arm/Group Description:	All patients (i.e., both patients who were dialysis dependent and patients who were dialysis independent at baseline)
Overall Number of Participants Analyzed	15
Geometric Mean (Full Range); Unit of Measure: L/kg
	0.13; (0.07 to 0.21)

14. Secondary Outcome

Title	Pharmacodynamics (IgG Degradation Measured as Remaining Concentration of Intact and Single Cleaved IgG)
Description	Imlifidase specifically cleaves all subclasses of human IgG rapidly and efficiently. The cleaving process involves two steps: (i) intact IgG to single cleaved IgG followed by (ii) single cleaved IgG to completely cleaved IgG (one F(ab')2- and one homodimeric Fc-fragment) The electroluminescence analysis method used measures the sum of intact and single cleaved IgG in serum. The efficacy of imlifidase is evaluated as remaining concentration of intact and single cleaved IgG in serum after treatment.
Time Frame	Pre-dose up to 6 months after imlifidase administration

Outcome Measure Data

Analysis Population Description

Some patients had missing data at some timepoints

Arm/Group Title		All Patients
Arm/Group Description:		All patients (i.e., both patients who were dialysis dependent and patients who were dialysis independent at baseline)
Overall Number of Participants Analyzed		15
Mean (Standard Deviation); Unit of Measure: mg/mL
Pre-dose	Number Analyzed	15 participants
		6.66 (2.94)
2 hours	Number Analyzed	15 participants
		0.17 (0.12)
6 hours	Number Analyzed	15 participants
		0.08 (0.05)
24 hours	Number Analyzed	14 participants
		0.08 (0.05)
Day 3	Number Analyzed	15 participants
		0.09 (0.05)
Day 7	Number Analyzed	15 participants
		0.85 (1.56)
Day 10	Number Analyzed	15 participants
		1.58 (1.69)
Day 15	Number Analyzed	15 participants
		2.64 (2.42)
Day 22	Number Analyzed	15 participants
		2.94 (2.34)
Day 29	Number Analyzed	15 participants
		3.94 (2.18)
Day 50	Number Analyzed	14 participants
		4.29 (2.05)
Day 180	Number Analyzed	14 participants
		6.76 (2.49)

15. Secondary Outcome

Title	Anti-imlifidase Antibodies (ADA)
Description	Determination of anti-imlifidase antibody concentration
Time Frame	Up to 6 months after dosing

Outcome Measure Data

Analysis Population Description

Some missing data at Day 50, Day 93 and Day 180

Arm/Group Title		All Patients
Arm/Group Description:		All patients (i.e., irrespective of dialysis dependency at baseline)
Overall Number of Participants Analyzed		15
Mean (Standard Deviation); Unit of Measure: mg/L
Pre-imlifidase	Number Analyzed	15 participants
		9.00 (4.17)
Day 7	Number Analyzed	15 participants
		4.32 (5.29)
Day 15	Number Analyzed	15 participants
		752 (728)
Day 22	Number Analyzed	15 participants
		744 (736)
Day 29	Number Analyzed	15 participants
		609 (493)
Day 50	Number Analyzed	14 participants
		547 (580)
Day 93	Number Analyzed	12 participants
		327 (263)
Day 180	Number Analyzed	14 participants
		242 (280)

16. Secondary Outcome

Title	Renal Histology
Description	Kidney biopsies were classified according to the histopathologic classification for antineutrophil cytoplasmic antibodies (ANCA)-associated glomerulonephritis developed by Berden et al. 2010. This classification has previously been applied in a study of 123 anti-GBM disease patients (von Daalen et al 2018). Histopathologic class: Focal (≤50% normal glomeruli); Crescentic (≥50% glomeruli with cellular crescents); Mixed (<50% normal, <50%crescentic, <50% globally sclerotic glomeruli); Sclerotic (≥50% globally sclerotic glomeruli) In addition information on the histological activity and kidney outcome was provided. Focal class is associated with favourable kidney outcome, whereas sclerotic carries a poor outcome. Crescentic/mixed class could have an intermediate outcome between focal and sclerotic. Immunofluorescence performed at the local hospitals was also used to assess linear IgG deposits which is a hallmark of anti-GBM antibody disease.
Time Frame	Before administration of imlifidase (0-33 days) and after administration of imlifidase (3-6 days)

Outcome Measure Data

Analysis Population Description

During the study, 14 kidney biopsies were taken from 10 of the 15 included patients. 10 biopsies were taken before administration of imlifidase and 4 after administration of imlifidase.

Arm/Group Title	14 Biopsies Collected From 10 Patients in the Study
Arm/Group Description:	10 biopsies were collected before imlifidase administration and 4 biopsies were collected after imlifidase administration
Overall Number of Participants Analyzed	10
Overall Number of Units Analyzed; Type of Units Analyzed: Biopsies	14
Measure Type: Number; Unit of Measure: Biopsies
Crescentic	9
Mixed	4
Sclerotic	1
Linear IgG deposits	11

Adverse Events

Time Frame	Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study. A treatment emergent adverse event (TEAE) is defined as any AE occurring after imlifidase administration and within the time of the residual drug effect period (i.e. 28 days after admin).
Adverse Event Reporting Description	Data on AEs were obtained if spontaneously reported, if reported in response to an open question, or if revealed by observation. All Serious Adverse Events (SAEs) were post-TEAEs and those are listed in the "SAE" table. "Other (Not Including Serious) Adverse Events" presents all reported AEs in the study (47 TEAEs and 35 post-TEAEs).
Arm/Group Title	Safety Analysis Set
Arm/Group Description	All patients who have received imlifidase.
All-Cause Mortality
	Safety Analysis Set
	Affected / at Risk (%)
Total	1/15 (6.67%)
Serious Adverse Events
	Safety Analysis Set
	Affected / at Risk (%)	# Events
Total	5/15 (33.33%)
Cardiac disorders
Cardiac failure † 1	1/15 (6.67%)	1
Gastrointestinal disorders
Diarrhea † 1	1/15 (6.67%)	1
Vomiting † 1	1/15 (6.67%)	1
General disorders
Pyrexia † 1	1/15 (6.67%)	1
Infections and infestations
Viral infection † 1	1/15 (6.67%)	1
Pneumonia † 1	1/15 (6.67%)	1
Metabolism and nutrition disorders
Dehydration † 1	1/15 (6.67%)	1
Musculoskeletal and connective tissue disorders
Back pain † 1	1/15 (6.67%)	1
1 Term from vocabulary, MedDRA (23.1); † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Safety Analysis Set
	Affected / at Risk (%)	# Events
Total	15/15 (100.00%)
Blood and lymphatic system disorders
Anaemia † 1	6/15 (40.00%)	6
Leukopenia † 1	2/15 (13.33%)	2
Lymphopenia † 1	1/15 (6.67%)	1
Thrombocytopenia † 1	1/15 (6.67%)	1
Ear and labyrinth disorders
Tinnitus † 1	2/15 (13.33%)	3
Eye disorders
Foreign body sensation in eyes † 1	1/15 (6.67%)	1
Vision blurred † 1	1/15 (6.67%)	1
Gastrointestinal disorders
Diarrhoea † 1	2/15 (13.33%)	2
Nausea † 1	4/15 (26.67%)	4
Vomiting † 1	2/15 (13.33%)	2
Mouth ulceration † 1	1/15 (6.67%)	1
Rectal haemorrhage † 1	1/15 (6.67%)	1
General disorders
Fatigue † 1	1/15 (6.67%)	1
Influenza like illness † 1	1/15 (6.67%)	1
Chest discomfort † 1	1/15 (6.67%)	1
Immune system disorders
Cryoglobulinaemia † 1	1/15 (6.67%)	1
Hypogammaglobulinaemia † 1	1/15 (6.67%)	1
Infections and infestations
Clostridium difficile infection † 1	1/15 (6.67%)	1
Herpes zoster † 1	1/15 (6.67%)	1
Pneumonia klebsiella † 1	1/15 (6.67%)	1
Urinary tract infection † 1	2/15 (13.33%)	2
Nasopharyngitis † 1	1/15 (6.67%)	1
Cystitis † 1	1/15 (6.67%)	3
Clostridium difficile colitis † 1	1/15 (6.67%)	1
Gastroenteritis † 1	1/15 (6.67%)	1
Injury, poisoning and procedural complications
Humerus fracture † 1	1/15 (6.67%)	1
Fall † 1	1/15 (6.67%)	1
Limb injury † 1	1/15 (6.67%)	1
Investigations
Blood iron decreased † 1	1/15 (6.67%)	1
Red blood cell count decreased † 1	1/15 (6.67%)	1
Anti-glomerular basement membrane antibody positive † 1	1/15 (6.67%)	1
Borrelia test positive † 1	1/15 (6.67%)	1
Metabolism and nutrition disorders
Decreased appetite † 1	1/15 (6.67%)	1
Hyperglycaemia † 1	2/15 (13.33%)	2
Hyperphosphataemia † 1	1/15 (6.67%)	1
Steroid diabetes † 1	1/15 (6.67%)	1
Hypoglycaemia † 1	1/15 (6.67%)	1
Hyperkalaemia † 1	1/15 (6.67%)	1
Musculoskeletal and connective tissue disorders
Arthralgia † 1	1/15 (6.67%)	1
Muscle spasms † 1	1/15 (6.67%)	1
Back pain † 1	1/15 (6.67%)	1
Tendon pain † 1	1/15 (6.67%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma † 1	1/15 (6.67%)	1
Nervous system disorders
Cognitive disorder † 1	1/15 (6.67%)	1
Dizziness † 1	1/15 (6.67%)	1
Headache † 1	1/15 (6.67%)	1
Post herpetic neuralgia † 1	1/15 (6.67%)	1
Renal and urinary disorders
Haematuria † 1	1/15 (6.67%)	1
Reproductive system and breast disorders
Menorrhagia † 1	1/15 (6.67%)	1
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction † 1	1/15 (6.67%)	1
Dyspnoea † 1	1/15 (6.67%)	2
Sinus pain † 1	1/15 (6.67%)	1
Chronic obstructive pulmonary disease † 1	1/15 (6.67%)	1
Skin and subcutaneous tissue disorders
Ecchymosis † 1	1/15 (6.67%)	1
Hyperhidrosis † 1	1/15 (6.67%)	1
Rash erythematous † 1	1/15 (6.67%)	1
Urticaria † 1	1/15 (6.67%)	1
Dermatitis allergic † 1	1/15 (6.67%)	1
Vascular disorders
Hypertension † 1	3/15 (20.00%)	3
Pelvic venous thrombosis † 1	1/15 (6.67%)	1
Thrombophlebitis † 1	1/15 (6.67%)	1
Deep vein thrombosis † 1	1/15 (6.67%)	1
1 Term from vocabulary, MedDRA (23.1); † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Professor Mårten Segelmark
• Organization: Linköping University
• Phone: +46 70 287 19 44
• EMail: marten.segelmark@liu.se

Publications:

Berden AE, Ferrario F, Hagen EC, Jayne DR, Jennette JC, Joh K, Neumann I, Noel LH, Pusey CD, Waldherr R, Bruijn JA, Bajema IM. Histopathologic classification of ANCA-associated glomerulonephritis. J Am Soc Nephrol. 2010 Oct;21(10):1628-36. doi: 10.1681/ASN.2010050477. Epub 2010 Jul 8.

van Daalen EE, Jennette JC, McAdoo SP, Pusey CD, Alba MA, Poulton CJ, Wolterbeek R, Nguyen TQ, Goldschmeding R, Alchi B, Griffiths M, de Zoysa JR, Vincent B, Bruijn JA, Bajema IM. Predicting Outcome in Patients with Anti-GBM Glomerulonephritis. Clin J Am Soc Nephrol. 2018 Jan 6;13(1):63-72. doi: 10.2215/CJN.04290417. Epub 2017 Nov 21.

• Responsible Party: Mårten Segelmark, Linkoeping University
• ClinicalTrials.gov Identifier: NCT03157037
• Other Study ID Numbers: GOOD-IDES-01
• First Submitted: May 11, 2017
• First Posted: May 17, 2017
• Results First Submitted: December 20, 2021
• Results First Posted: April 7, 2022
• Last Update Posted: April 7, 2022