A Study of Cemdisiran in Adults With Immunoglobulin A Nep... | NCT03841448

NCT03841448

ID	Type	Description	Link
2018-002716-27	EudraCT Number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Double-Blind Treatment (DBT) Period: Cemdisiran	Experimental	Participants received cemdisiran, 600 milligrams (mg), subcutaneous (SC) injection, once every 4 weeks (Q4W) in combination with standard of care treatment up to a maximum of 38 weeks in the DBT period.	Drug: Cemdisiran
DBT Period: Placebo	Placebo Comparator	Participants received cemdisiran matching placebo, SC injection, Q4W in combination with standard of care treatment up to a maximum of 38 weeks in the DBT period.	Drug: Placebo
DBT Period: Cemdisiran to Open-Label Extension (OLE) Period: Cemdisiran	Experimental	Participants who were randomized to receive cemdisiran in the DBT period continued receiving cemdisiran, 600 mg, SC injection, Q4W in combination with standard of care treatment up to a maximum of 88 weeks in the OLE treatment period.	Drug: Cemdisiran
DBT Period: Placebo to OLE Period: Cemdisiran	Placebo Comparator	Participants who were randomized to receive cemdisiran matching placebo in the DBT period started receiving cemdisiran, 600 mg, SC injection, Q4W in combination with standard of care treatment up to a maximum of 88 weeks in the OLE treatment period.	Drug: Cemdisiran

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Normal saline (0.9% NaCl) matching volume of cemdisiran doses were administered SC.	DBT Period: Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent Change From Baseline in UPCR as Measured in 24-hour Urine at Week 32	UPCR is a way of assessing the amount of protein in the urine. The primary analysis for UPCR was performed using Mixed-Effect Model Repeated Measures (MMRM) approach. Geometric mean (GM)ratios were obtained by exponentially back-transforming the arithmetic mean of change in log-transformed 24h UPCR. Standard error of the mean (SEM) was calculated as exponential (mean of change in log-transformed data) * (standard error of change in log-transformed data). Adjusted GM ratio to baseline and 90% confidence interval (CIs) were calculated by exponentially back-transforming the model-based least square (LS) mean and the corresponding 90% CI.	Baseline to Week 32

Secondary Outcomes

Measure	Description	Time Frame
Percent Change From Baseline in 24-hour Proteinuria at Week 32	Proteinuria is high levels of protein in the urine. 24-hour proteinuria assessment included 24-hour urine collections to assess total protein excretion per 24 hours. Analysis was performed using the MMRM model. GM ratios were obtained by exponentially back-transforming the arithmetic mean of change in log-transformed 24h urine protein (UP). SEM was calculated as exp (mean of change in log-transformed data) *(standard error of change in log-transformed data). Adjusted GM ratio to baseline and 90% CIs are calculated by exponentially back-transforming the model-based LS Means and the corresponding 90% CI.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Medical Director	Alnylam Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Trial Site		Vancouver	British Columbia		Canada
Clinical Trial Site

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	DBT Period: Placebo	Participants received cemdisiran matching placebo, subcutaneous (SC) injection, once every 4 weeks (Q4W) in combination with standard of care treatment up to a maximum of 38 weeks in the DBT period.
FG001	DBT Period: Cemdisiran

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 19, 2021	Sep 12, 2023

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

FG0009 subjects
FG00122 subjects
FG0020 subjects
FG0030 subjects

Safety Analysis Set included all participants who received any amount of study drug.

Arm/Group Information

ID	Title	Description
BG000	DBT Period: Placebo	Participants received cemdisiran matching placebo, SC injection, Q4W in combination with standard of care treatment up to a maximum of 38 weeks in the DBT period.
BG001	DBT Period: Cemdisiran	Participants received cemdisiran, 600 mg, SC injection, Q4W in combination with standard of care treatment up to a maximum of 38 weeks in the DBT period.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00037.6± 10.4 BG00140.5± 10.1 BG00239.7± 10.1

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0006 BG0019 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0001 BG0013 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Asian

Title	Measurements
	BG0004 BG00112 BG002

Urine Protein to Creatinine Ratio

Mean

Standard Deviation

g/g

Title

Denominators

Categories

Title	Measurements
	BG0001.972± 0.815 BG0011.554± 1.032 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percent Change From Baseline in UPCR as Measured in 24-hour Urine at Week 32

UPCR is a way of assessing the amount of protein in the urine. The primary analysis for UPCR was performed using Mixed-Effect Model Repeated Measures (MMRM) approach. Geometric mean (GM)ratios were obtained by exponentially back-transforming the arithmetic mean of change in log-transformed 24h UPCR. Standard error of the mean (SEM) was calculated as exponential (mean of change in log-transformed data) * (standard error of change in log-transformed data). Adjusted GM ratio to baseline and 90% confidence interval (CIs) were calculated by exponentially back-transforming the model-based least square (LS) mean and the corresponding 90% CI.

mITT Analysis Set included all participants who received any amount of study drug and had at least one post baseline 24-hour UPCR assessment. Number analyzed is the number of participants with data available for analysis at the specified timepoint.

Posted

Geometric Mean

Standard Error

percent change

Baseline to Week 32

ID	Title	Description
OG000	DBT Period: Placebo	Participants received cemdisiran matching placebo, SC injection, Q4W in combination with standard of care treatment up to a maximum of 38 weeks in the DBT period.
OG001	DBT Period: Cemdisiran	Participants received cemdisiran, 600 mg, SC injection, Q4W in combination with standard of care treatment up to a maximum of 38 weeks in the DBT period.

Units	Counts
Participants	OG0009 OG00122

Title

Denominators

Categories

Title	Measurements
	OG0001.095± 0.258 OG0010.686± 0.098

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		MMRM		0.1032		Placebo-adjusted GM Percent Change	-37.367			2-Sided	90	-60.951	0.460			Placebo-adjusted GM percent change, 90% CIs were calculated by exponentially back-transforming the model based LS mean difference (cemdisiran - placebo) and the corresponding 90% CI then subtracting by 1.		Superiority

Secondary

Percent Change From Baseline in 24-hour Proteinuria at Week 32

Proteinuria is high levels of protein in the urine. 24-hour proteinuria assessment included 24-hour urine collections to assess total protein excretion per 24 hours. Analysis was performed using the MMRM model. GM ratios were obtained by exponentially back-transforming the arithmetic mean of change in log-transformed 24h urine protein (UP). SEM was calculated as exp (mean of change in log-transformed data) *(standard error of change in log-transformed data). Adjusted GM ratio to baseline and 90% CIs are calculated by exponentially back-transforming the model-based LS Means and the corresponding 90% CI.

Posted

Geometric Mean

Standard Error

percent change

Baseline to Week 32

ID	Title	Description
OG000	DBT Period: Placebo	Participants received cemdisiran matching placebo, SC injection, Q4W in combination with standard of care treatment up to a maximum of 38 weeks in the DBT period.
OG001	DBT Period: Cemdisiran	Participants received cemdisiran, 600 mg, SC injection, Q4W in combination with standard of care treatment up to a maximum of 38 weeks in the DBT period.

Secondary

Percentage of Participants With Partial Clinical Remission at Week 32

Partial clinical remission was defined as having UP <1.0 g/24-hours.

mITT Analysis Set included all participants who received any amount of study drug and had at least one post baseline 24-hour UPCR assessment.

Posted

Number

percentage of participants

Week 32

ID	Title	Description
OG000	DBT Period: Placebo	Participants received cemdisiran matching placebo, SC injection, Q4W in combination with standard of care treatment up to a maximum of 38 weeks in the DBT period.
OG001	DBT Period: Cemdisiran	Participants received cemdisiran, 600 mg, SC injection, Q4W in combination with standard of care treatment up to a maximum of 38 weeks in the DBT period.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With >50% Reduction in 24-hour Proteinuria at Week 32

mITT Analysis Set included all participants who received any amount of study drug and had at least one post baseline 24-hour UPCR assessment. Percentages are rounded off to the nearest decimal point.

Posted

Number

percentage of participants

Week 32

ID	Title	Description
OG000	DBT Period: Placebo	Participants received cemdisiran matching placebo, SC injection, Q4W in combination with standard of care treatment up to a maximum of 38 weeks in the DBT period.
OG001	DBT Period: Cemdisiran	Participants received cemdisiran, 600 mg, SC injection, Q4W in combination with standard of care treatment up to a maximum of 38 weeks in the DBT period.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in UPCR as Measured in a Spot Urine at Week 32

UPCR was calculated by dividing the level of protein in a spot urine test by the creatinine level. Analysis was performed using MMRM model. GM ratios were obtained by exponentially back-transforming the arithmetic mean of change in log-transformed spot UPCR. SEM was calculated as exp (mean of change in log-transformed data) *(standard error of change in log-transformed data). Adjusted GM ratio to baseline and 90% CIs are calculated by exponentially back-transforming the model-based LS Means and the corresponding 90% CI.

Posted

Geometric Mean

Standard Error

gram per gram (g/g)

Baseline to Week 32

ID	Title	Description
OG000	DBT Period: Placebo	Participants received cemdisiran matching placebo, SC injection, Q4W in combination with standard of care treatment up to a maximum of 38 weeks in the DBT period.
OG001	DBT Period: Cemdisiran	Participants received cemdisiran, 600 mg, SC injection, Q4W in combination with standard of care treatment up to a maximum of 38 weeks in the DBT period.

Secondary

Number of Participants With Change From Baseline in Hematuria at Week 32

Hematuria is the presence of blood in the urine. Hematuria from spot urine collections was evaluated to assess the effect of cemdisiran on disease course in participants. The degree of hematuria was assessed by microscopic examination of the spun urine sediment (red blood cell (RBC)/ high power field [hpf]) and by urine dipstick.

mITT Analysis Set included all participants who received any amount of study drug and had at least one post-baseline 24-hour UPCR assessment. Overall number of participants analyzed is the number of participants with data available for analysis.

Posted

Count of Participants

Participants

Baseline to Week 32

ID	Title	Description
OG000	DBT Period: Placebo	Participants received cemdisiran matching placebo, SC injection, Q4W in combination with standard of care treatment up to a maximum of 38 weeks in the DBT period.
OG001	DBT Period: Cemdisiran	Participants received cemdisiran, 600 mg, SC injection, Q4W in combination with standard of care treatment up to a maximum of 38 weeks in the DBT period.

Units	Counts

Secondary

Number of Participants With Adverse Events (AEs)

An AE is any untoward medical occurrence in a participant or clinical investigational subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

DBT Period: Safety Analysis Set: All participants who received any amount of study drug.

DBT + OLE and All Cemdisiran: All Cemdisiran Treated Set: All participants who received at least one dose of cemdisiran, including participants who received cemdisiran during the DB Period and participants who first take placebo during the DB Period and switch to cemdisiran during the OLE Period.

Posted

Count of Participants

Participants

Up to 126 weeks

ID	Title	Description
OG000	DBT Period: Placebo	Participants received cemdisiran matching placebo, subcutaneous (SC) injection, once every 4 weeks (Q4W) in combination with standard of care treatment up to a maximum of 38 weeks in the DBT period.
OG001	DBT Period: Cemdisiran	Participants received cemdisiran, 600 milligrams (mg), SC injection, Q4W in combination with standard of care treatment up to a maximum of 38 weeks in the DBT period.
OG002	DBT Period: Placebo + OLE Period: Cemdisiran

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	DBT Period: Placebo	Participants received cemdisiran matching placebo, SC injection, Q4W in combination with standard of care up to a maximum of 38 weeks in the DBT period.	1	9	0	9	8	9
EG001	DBT Period: Cemdisiran	Participants received cemdisiran, 600 mg, SC injection, Q4W in combination with standard of care treatment up to a maximum of 38 weeks in the DBT period.	1	22	1	22	19	22
EG002	DBT Period: Placebo + OLE Period: Cemdisiran	Participants who were randomized to receive cemdisiran matching placebo in the DBT period started receiving cemdisiran, 600 mg, SC injection, Q4W in combination with standard of care treatment up to a maximum of 88 weeks in the OLE treatment period. The data reported for this group is for the OLE Period only, in which all participants were receiving treatment with cemdisiran.	0	8	3	8	8	8
EG003	DBT Period: Cemdisiran + OLE Period: Cemdisiran	Participants who were randomized to receive cemdisiran in the DBT period continued receiving cemdisiran, 600 mg, SC injection, Q4W in combination with standard of care treatment up to a maximum of 88 weeks in the OLE treatment period. The data reported for this group is for the DBT and OLE Periods inclusively, in which all participants were receiving treatment with cemdisiran.	1	22	2	22	22	22
EG004	All Cemdisiran	All participants who received at least one dose of cemdisiran, including participants who received cemdisiran during the DB Period and participants who first received placebo during the DB Period and switched to cemdisiran during the OLE Period.	2	30	5	30	30	30

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cardiopulmonary failure	Cardiac disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected0 at risk EG0011 affected1 at risk EG0020 affected1 at risk EG0031 affected22 at risk EG0041 affected30 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0021 affected8 at risk EG003
Helicobacter gastritis	Infections and infestations	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0020 affected8 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0021 affected8 at risk EG003
End stage renal disease	Renal and urinary disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0021 affected8 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal distension	Gastrointestinal disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected22 at risk EG0020 affected8 at risk EG0031 affected22 at risk EG0041 affected30 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected22 at risk EG0020 affected8 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected22 at risk EG0020 affected8 at risk EG003
Activated partial thromboplastin time prolonged	Investigations	MedDRA version 23.0	Systematic Assessment	EG0001 affected9 at risk EG0010 affected22 at risk EG0020 affected8 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0012 affected22 at risk EG0021 affected8 at risk EG003
Animal bite	Injury, poisoning and procedural complications	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected22 at risk EG0020 affected8 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0021 affected8 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0012 affected22 at risk EG0021 affected8 at risk EG003
Asthenia	General disorders	MedDRA version 23.0	Systematic Assessment	EG0001 affected9 at risk EG0010 affected22 at risk EG0020 affected8 at risk EG003
Asymptomatic COVID-19	Infections and infestations	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0020 affected8 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected22 at risk EG0020 affected8 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA version 23.0	Systematic Assessment	EG0002 affected9 at risk EG0010 affected22 at risk EG0021 affected8 at risk EG003
Blood pressure increased	Investigations	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected22 at risk EG0020 affected8 at risk EG003
Bronchitis	Infections and infestations	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0021 affected8 at risk EG003
Cerumen impaction	Ear and labyrinth disorders	MedDRA version 23.0	Systematic Assessment	EG0001 affected9 at risk EG0010 affected22 at risk EG0020 affected8 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0021 affected8 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0020 affected8 at risk EG003
COVID-19	Infections and infestations	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0012 affected22 at risk EG0025 affected8 at risk EG003
Deafness unilateral	Ear and labyrinth disorders	MedDRA version 23.0	Systematic Assessment	EG0001 affected9 at risk EG0010 affected22 at risk EG0020 affected8 at risk EG003
Dermatitis atopic	Skin and subcutaneous tissue disorders	MedDRA version 23.0	Systematic Assessment	EG0001 affected9 at risk EG0010 affected22 at risk EG0020 affected8 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected22 at risk EG0020 affected8 at risk EG003
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0020 affected8 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected22 at risk EG0020 affected8 at risk EG003
Dyshidrotic eczema	Skin and subcutaneous tissue disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0020 affected8 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0021 affected8 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.0	Systematic Assessment	EG0001 affected9 at risk EG0010 affected22 at risk EG0021 affected8 at risk EG003
Eyelid infection	Infections and infestations	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected22 at risk EG0020 affected8 at risk EG003
Gout	Metabolism and nutrition disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected22 at risk EG0020 affected8 at risk EG003
Headache	Nervous system disorders	MedDRA version 23.0	Systematic Assessment	EG0001 affected9 at risk EG0011 affected22 at risk EG0020 affected8 at risk EG003
Hot flush	Vascular disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected22 at risk EG0020 affected8 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected22 at risk EG0020 affected8 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0021 affected8 at risk EG003
Hyperparathyroidism secondary	Endocrine disorders	MedDRA version 23.0	Systematic Assessment	EG0001 affected9 at risk EG0010 affected22 at risk EG0020 affected8 at risk EG003
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0022 affected8 at risk EG003
Hypertension	Vascular disorders	MedDRA version 23.0	Systematic Assessment	EG0001 affected9 at risk EG0010 affected22 at risk EG0022 affected8 at risk EG003
Influenza	Infections and infestations	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected22 at risk EG0021 affected8 at risk EG003
Injection site bruising	General disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0021 affected8 at risk EG003
Injection site reaction	General disorders	MedDRA version 23.0	Systematic Assessment	EG0002 affected9 at risk EG0019 affected22 at risk EG0025 affected8 at risk EG003
Injection site recall reaction	General disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0012 affected22 at risk EG0023 affected8 at risk EG003
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA version 23.0	Systematic Assessment	EG0001 affected9 at risk EG0010 affected22 at risk EG0020 affected8 at risk EG003
Keratosis obturans	Ear and labyrinth disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected22 at risk EG0020 affected8 at risk EG003
Limb discomfort	Musculoskeletal and connective tissue disorders	MedDRA version 23.0	Systematic Assessment	EG0001 affected9 at risk EG0010 affected22 at risk EG0020 affected8 at risk EG003
Low density lipoprotein increased	Investigations	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected22 at risk EG0020 affected8 at risk EG003
Lymphocyte count decreased	Investigations	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0020 affected8 at risk EG003
Migraine	Nervous system disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0020 affected8 at risk EG003
Mouth ulceration	Gastrointestinal disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0020 affected8 at risk EG003
Muscle twitching	Musculoskeletal and connective tissue disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected22 at risk EG0020 affected8 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA version 23.0	Systematic Assessment	EG0003 affected9 at risk EG0010 affected22 at risk EG0021 affected8 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected22 at risk EG0022 affected8 at risk EG003
Oedema peripheral	General disorders	MedDRA version 23.0	Systematic Assessment	EG0001 affected9 at risk EG0013 affected22 at risk EG0021 affected8 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0012 affected22 at risk EG0020 affected8 at risk EG003
Pain	General disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected22 at risk EG0020 affected8 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA version 23.0	Systematic Assessment	EG0001 affected9 at risk EG0010 affected22 at risk EG0020 affected8 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected22 at risk EG0020 affected8 at risk EG003
Pyrexia	General disorders	MedDRA version 23.0	Systematic Assessment	EG0001 affected9 at risk EG0011 affected22 at risk EG0022 affected8 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0012 affected22 at risk EG0021 affected8 at risk EG003
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA version 23.0	Systematic Assessment	EG0001 affected9 at risk EG0010 affected22 at risk EG0020 affected8 at risk EG003
Renal impairment	Renal and urinary disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected22 at risk EG0021 affected8 at risk EG003
Restless legs syndrome	Nervous system disorders	MedDRA version 23.0	Systematic Assessment	EG0001 affected9 at risk EG0010 affected22 at risk EG0020 affected8 at risk EG003
Rhinitis	Infections and infestations	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected22 at risk EG0020 affected8 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0012 affected22 at risk EG0020 affected8 at risk EG003
Splenomegaly	Blood and lymphatic system disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0020 affected8 at risk EG003
Suprapubic pain	General disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected22 at risk EG0020 affected8 at risk EG003
Testicular pain	Reproductive system and breast disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected22 at risk EG0020 affected8 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0020 affected8 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected22 at risk EG0020 affected8 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0020 affected8 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected22 at risk EG0020 affected8 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected22 at risk EG0020 affected8 at risk EG003
Vaccination site reaction	General disorders	MedDRA version 23.0	Systematic Assessment	EG0001 affected9 at risk EG0010 affected22 at risk EG0020 affected8 at risk EG003
Vaginal discharge	Reproductive system and breast disorders	MedDRA version 23.0	Systematic Assessment	EG0001 affected9 at risk EG0010 affected22 at risk EG0020 affected8 at risk EG003
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0021 affected8 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0021 affected8 at risk EG003
Vulvovaginal mycotic infection	Infections and infestations	MedDRA version 23.0	Systematic Assessment	EG0001 affected9 at risk EG0010 affected22 at risk EG0020 affected8 at risk EG003
Weight increased	Investigations	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected22 at risk EG0021 affected8 at risk EG003
Oral Candidiasis	Infections and infestations	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0011 affected22 at risk EG0020 affected8 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0021 affected8 at risk EG003
Nephrogenic anaemia	Blood and lymphatic system disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0021 affected8 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0021 affected8 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0020 affected8 at risk EG003
Chest pain	General disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0020 affected8 at risk EG003
Fatigue	General disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0021 affected8 at risk EG003
Feeling cold	General disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0021 affected8 at risk EG003
Influenza like illness	General disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0020 affected8 at risk EG003
Malaise	General disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0020 affected8 at risk EG003
Swelling face	General disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0021 affected8 at risk EG003
Milk allergy	Immune system disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0020 affected8 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0021 affected8 at risk EG003
Cystitis	Infections and infestations	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0021 affected8 at risk EG003
Helicobacter infection	Infections and infestations	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0020 affected8 at risk EG003
Pneumonia	Infections and infestations	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0020 affected8 at risk EG003
Superinfection	Infections and infestations	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0021 affected8 at risk EG003
Tooth infection	Infections and infestations	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0020 affected8 at risk EG003
Viral infection	Infections and infestations	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0021 affected8 at risk EG003
Viral rash	Infections and infestations	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0020 affected8 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0020 affected8 at risk EG003
Muscle contusion	Injury, poisoning and procedural complications	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0020 affected8 at risk EG003
Skin laceration	Injury, poisoning and procedural complications	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0020 affected8 at risk EG003
Gamma-glutamyltransferase abnormal	Investigations	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0020 affected8 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0021 affected8 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0021 affected8 at risk EG003
Liver function test increased	Investigations	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0021 affected8 at risk EG003
Urine sodium increased	Investigations	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0020 affected8 at risk EG003
Folate deficiency	Metabolism and nutrition disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0021 affected8 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0021 affected8 at risk EG003
Iron deficiency	Metabolism and nutrition disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0021 affected8 at risk EG003
Joint stiffness	Musculoskeletal and connective tissue disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0021 affected8 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0020 affected8 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0021 affected8 at risk EG003
Dizziness	Nervous system disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0020 affected8 at risk EG003
insomnia	Psychiatric disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0021 affected8 at risk EG003
Sleep disorder	Psychiatric disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0021 affected8 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0021 affected8 at risk EG003
Proteinuria	Renal and urinary disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0020 affected8 at risk EG003
Haematospermia	Reproductive system and breast disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0020 affected8 at risk EG003
Menorrhagia	Reproductive system and breast disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0020 affected8 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0020 affected8 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0022 affected8 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0020 affected8 at risk EG003
Sneezing	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0020 affected8 at risk EG003
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0020 affected8 at risk EG003
Hypotension	Vascular disorders	MedDRA version 23.0	Systematic Assessment	EG0000 affected9 at risk EG0010 affected22 at risk EG0020 affected8 at risk EG003

First MCP Posted Date

ID	Term
D005922	Glomerulonephritis, IGA

Ancestor Terms

ID	Term
D005921	Glomerulonephritis
D009393	Nephritis
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

Units	Counts
Participants	OG0009 OG00122

Participants who were randomized to receive cemdisiran matching placebo in the DBT period started receiving cemdisiran, 600 mg, SC injection, Q4W in combination with standard of care treatment up to a maximum of 88 weeks in the OLE treatment period. The data reported for this group is for the OLE Period only, in which all participants were receiving treatment with cemdisiran.

EG0041 affected30 at risk

EG0042 affected30 at risk

EG0040 affected30 at risk

EG0043 affected30 at risk

EG0041 affected30 at risk

EG0043 affected30 at risk

EG0040 affected30 at risk

EG0041 affected30 at risk

EG0042 affected30 at risk

EG0041 affected30 at risk

EG0040 affected30 at risk

EG0041 affected30 at risk

EG0042 affected30 at risk

EG00414 affected30 at risk

EG0040 affected30 at risk

EG0041 affected30 at risk

EG0042 affected30 at risk

EG0041 affected30 at risk

EG0040 affected30 at risk

EG0042 affected30 at risk

EG0043 affected30 at risk

EG0042 affected30 at risk

EG0041 affected30 at risk

EG00414 affected30 at risk

EG0045 affected30 at risk

EG0040 affected30 at risk

EG0041 affected30 at risk

EG0043 affected30 at risk

EG0044 affected30 at risk

EG0042 affected30 at risk

EG0041 affected30 at risk

EG0040 affected30 at risk

EG0042 affected30 at risk

EG0045 affected30 at risk

EG0044 affected30 at risk

EG0040 affected30 at risk

EG0042 affected30 at risk

EG0040 affected30 at risk

EG0041 affected30 at risk

EG0042 affected30 at risk

EG0041 affected30 at risk

EG0044 affected30 at risk

EG0042 affected30 at risk

EG0043 affected30 at risk

EG0040 affected30 at risk

EG0041 affected30 at risk

EG0040 affected30 at risk

EG0042 affected30 at risk

EG0041 affected30 at risk

EG0042 affected30 at risk

EG0041 affected30 at risk

EG0042 affected30 at risk

EG0041 affected30 at risk

EG0042 affected30 at risk

EG0041 affected30 at risk