Trial · NCT03095118

Daratumumab in Treatment of PGNMID and C3 GN

NCT03095118, Phase 2, Completed, Fernando Fervenza; results first posted 2021-07-16

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Daratumumab in Treatment of PGNMID and C3 GN. Trials, record NCT03095118. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03095118

On this page

Trial

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

Title: Daratumumab in Treatment of PGNMID and C3 GN
NCT number: NCT03095118
Status: Completed
Phases: Phase 2
Enrollment: 12 participants, actual
Lead sponsor: Fernando Fervenza
Conditions: Membranoproliferative Glomerulonephritis
Interventions: Daratumumab
First posted: 2017-03-29
Last updated: 2022-08-31
Results first posted: 2021-07-16

Source ClinicalTrials.gov

Registered outcomes9

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

List	Outcome	Time frame	Description
Primary	Number of Treatment-Emergent Adverse Events	1 year	Number of treatment-emergent adverse events as defined as major infection (defined as the development of pneumonia, severe urinary tract infection/pyelonephritis, sepsis, meningitis), grade 3 or 4 anemia, leukopenia, or thrombocytopenia.
Secondary	Remission Status at 6 Months	6 months	The number of subjects to reach either complete remission or partial remission at 6 months after infusion.
Secondary	Remission Status at 12 Months	12 months	The number of subjects to reach either complete remission or partial remission at 12 months after infusion.
Secondary	Proteinuria at Baseline	Baseline	Measured using 24 hour urine collection reported in mg/24h
Secondary	Proteinuria at 6 Months	6 months	Measured using 24 hour urine collection reported in mg/24 h
Secondary	Proteinuria at 12 Months	12 months	Measured using 24 hour urine collection reported in mg/24h
Secondary	Serum Creatinine at Baseline	Baseline	Blood serum collected and reported in mg/dL
Secondary	Serum Creatinine at 6 Months	6 months	Blood serum collected and reported in mg/dL
Secondary	Serum Creatinine at 12 Months	12 months	Blood serum collected and reported in mg/dL

Source ClinicalTrials.gov

Outcomes9

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Number of Treatment-Emergent Adverse Events	1 year	Serious Adverse Events	NUMBER
SECONDARY	Remission Status at 6 Months	6 months	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Remission Status at 12 Months	12 months	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Proteinuria at Baseline	Baseline	mg/24h	MEDIAN
SECONDARY	Proteinuria at 6 Months	6 months	mg/24h	MEDIAN
SECONDARY	Proteinuria at 12 Months	12 months	mg/24h	MEDIAN
SECONDARY	Serum Creatinine at Baseline	Baseline	mg/dL	MEAN
SECONDARY	Serum Creatinine at 6 Months	6 months	mg/dL	MEAN
SECONDARY	Serum Creatinine at 12 Months	12 months	mg/dL	MEAN

Source ClinicalTrials.gov

Results by group9

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

Outcome	Group	Value	Spread	Units
Number of Treatment-Emergent Adverse Events	Daratumumab	5		Serious Adverse Events
Remission Status at 6 Months	Daratumumab	8		Participants
Remission Status at 12 Months	Daratumumab	9		Participants
Proteinuria at Baseline	Daratumumab	4346	Inter-Quartile Range 3245 to 7943	mg/24h
Proteinuria at 6 Months	Daratumumab	702	Inter-Quartile Range 435 to 3057	mg/24h
Proteinuria at 12 Months	Daratumumab	1264	Inter-Quartile Range 463 to 3645	mg/24h
Serum Creatinine at Baseline	Daratumumab	1.36	Standard Deviation 0.57	mg/dL
Serum Creatinine at 6 Months	Daratumumab	1.25	Standard Deviation 0.44	mg/dL
Serum Creatinine at 12 Months	Daratumumab	1.25	Standard Deviation 0.52	mg/dL

Source ClinicalTrials.gov

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Daratumumab	12
Overall Study	COMPLETED	Daratumumab	10
Overall Study	NOT COMPLETED	Daratumumab	2

Source ClinicalTrials.gov

Adverse events42

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	UTI	Renal and urinary disorders	Daratumumab	2	12	2
other	URI	Infections and infestations	Daratumumab	1	12	1
other	Cough	Respiratory, thoracic and mediastinal disorders	Daratumumab	7	12	16
other	Congestion	Respiratory, thoracic and mediastinal disorders	Daratumumab	7	12	10
other	Throat Irritation	General disorders	Daratumumab	6	12	11
other	Blurred Vision	Eye disorders	Daratumumab	4	12	4
other	Headache	Nervous system disorders	Daratumumab	3	12	3
other	Myalgia	Musculoskeletal and connective tissue disorders	Daratumumab	3	12	3
other	Tingling in feet	General disorders	Daratumumab	3	12	4
other	Flushed	General disorders	Daratumumab	2	12	3

1 to 10 of 42Source ClinicalTrials.gov

See all 42 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Daratumumab	0	12
Total, other adverse events	Daratumumab	12	12
Total, serious adverse events	Daratumumab	3	12

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
33685975	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 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.

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/NCT03095118

GET https://conductscience.org/api/trials/v1/NCT03095118/events?page=2

API reference For AI assistants