Trial · NCT00530075

Phase II Study on Gusperimus in Patients With Refractory Wegener's Granulomatosis

NCT00530075, Phase 2, Completed, Nippon Kayaku Co., Ltd.; results first posted 2017-03-06

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Phase II Study on Gusperimus in Patients With Refractory Wegener's Granulomatosis. Trials, record NCT00530075. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00530075

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Trial

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

Title: Phase II Study on Gusperimus in Patients With Refractory Wegener's Granulomatosis
NCT number: NCT00530075
Status: Completed
Phases: Phase 2
Enrollment: 45 participants, actual
Lead sponsor: Nippon Kayaku Co., Ltd.
Conditions: Wegener's Granulomatosis
Interventions: Gusperimus
First posted: 2007-09-17
Last updated: 2017-03-06
Results first posted: 2017-03-06

Source ClinicalTrials.gov

Registered outcomes8

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

List	Outcome	Time frame	Description
Primary	Remission of Vasculitis	At Entry (Day 1 of Cycle 1), Day 22 of cycles 1-6, up to 24 weeks	The primary efficacy outcome measure was remission of vasculitis. Complete remission was defined as a Birmingham vasculitis activity score (BVAS) of 0 sustained for at least 2 months. Partial remission was defined as a reduction in BVAS of 50% or more, sustained for at least 2 months, when compared with the BVAS at entry. Entry required active Wegener's granulomatosis with a BVAS \>= 4. Their disease had to be active, as measured with BVAS in which clinical manifestations caused by active vasculitis are scored on a list of predefined organ-specific items.
Secondary	Duration of Clinical Response	At Entry (Day 1 of Cycle 1), Day 22 of cycles 1-6, up to 24 weeks, End of treatment period, and 3 and 6 months of follow-up period	Time from Complete Remission or Partial Remission to Relapse.
Secondary	Haematuria	At Entry (Day 1 of Cycle 1), End of treatment period, up to 24 weeks	Assessment of anti-inflammatory activity of gusperimus using surrogate marker: number of hematuria-positive patients.
Secondary	Creatinine	At Entry (Day 1 of Cycle 1), End of treatment period, up to 24 weeks	Assessment of anti-inflammatory activity of gusperimus using surrogate marker: serum creatinine level
Secondary	ANCA	At Entry (Day 1 of Cycle 1), End of treatment period, up to 24 weeks	Assessment of anti-neutrophil cytoplasmic antibody (ANCA): Number of ANCA-positive patients was counted. ANCA are highly associatred with active WG, with c-ANCA titres observed in 90% of WG. In addition to their diagnostic value, it has been suggested that ANCA may have a predictive value for relapse in patients with systemic vasculitis.
Secondary	CRP	At Entry (Day 1 of Cycle 1), End of treatment period, up to 24 weeks	Assessment of anti-inflammatory activity of gusperimus using surrogate marker: serum C-reactive protein level.
Secondary	Vasculitis Damage Index (VDI)	At Entry (Day 1 of Cycle 1), End of treatment period, up to 24 weeks, 6 months of follow-up period	Assessment of the degree of irreversible damage due to the vasculitis using VDI scoring system. The VDI comprises 64 items of damage (grouped into 11 organ-based systems). Total VDI score is 0 - 64. The higher scores represent the more severe damage occurred in patients. The VDI score can either increase or remain the same over time.
Secondary	SF-36	At Entry (Day 1 of Cycle 1), End of treatment period, up to 24 weeks	Assessment of the impact of gusperimus on general health using the Short form-36 (SF-36) questionaire. The SF-36 is a self-report, 36 item survey measuring health-related quality-of-life. Thirty-five items are used to construct 8 scales: (1) physical functioning, (2) role physical, (3) bodily pain, (4) general health, (5) vitality, (6) social function, (7) role emotional, and (8) mental health. Raw scores are calculated as the sum of re-coded scale items and transformed to a 0 to 100 scale. If scores for all 8 scales are available, two summary measures known as component scores are derived: the Physical Health Component Score (PCS) and the Mental Health Component Score (MCS). First each scale standardized to the relevant population. Then PCS and MCS are calculated as the weighted sum of standardized scores. All scales and the component scores are positively scored so that higher scores represent better health-related quality-of-life.

Source ClinicalTrials.gov

Outcomes8

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Remission of Vasculitis	At Entry (Day 1 of Cycle 1), Day 22 of cycles 1-6, up to 24 weeks	Efficacy Population	Percentage of participants	NUMBER
SECONDARY	Duration of Clinical Response	At Entry (Day 1 of Cycle 1), Day 22 of cycles 1-6, up to 24 weeks, End of treatment period, and 3 and 6 months of follow-up period	Patients who had relapsed after achieved at least partial remission	Days	MEDIAN
SECONDARY	Haematuria	At Entry (Day 1 of Cycle 1), End of treatment period, up to 24 weeks	Efficacy population	Number of participants	NUMBER
SECONDARY	Creatinine	At Entry (Day 1 of Cycle 1), End of treatment period, up to 24 weeks	Efficacy population	micromol/L	MEDIAN
SECONDARY	ANCA	At Entry (Day 1 of Cycle 1), End of treatment period, up to 24 weeks	Efficacy Population	Number of participants	NUMBER
SECONDARY	CRP	At Entry (Day 1 of Cycle 1), End of treatment period, up to 24 weeks	Patients who had elevated CRP level (\> 6 mg/dL) at entry	mg/dL	MEDIAN
SECONDARY	Vasculitis Damage Index (VDI)	At Entry (Day 1 of Cycle 1), End of treatment period, up to 24 weeks, 6 months of follow-up period	Efficacy Population	Score on a scale	MEDIAN
SECONDARY	SF-36	At Entry (Day 1 of Cycle 1), End of treatment period, up to 24 weeks	Efficacy Population	Score on a scale	MEDIAN

Source ClinicalTrials.gov

Results by group17

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

Outcome	Group	Category	Value	Spread	Units
Remission of Vasculitis	Gusperimus		95		Percentage of participants
Duration of Clinical Response	Gusperimus		170	Full Range 44 to 316	Days
Haematuria	Gusperimus	At Entry	16		Number of participants
Haematuria	Gusperimus	End of treatment period	6		Number of participants
Creatinine	Gusperimus	At Entry	130	Full Range 58 to 299	micromol/L
Creatinine	Gusperimus	End of treatment period	132	Full Range 72 to 279	micromol/L
ANCA	Gusperimus	At Entry	39		Number of participants
ANCA	Gusperimus	End of treatment period	34		Number of participants
CRP	Gusperimus	At Entry	17.5	Full Range 7 to 88	mg/dL
CRP	Gusperimus	End of treatment period	9	Full Range 1 to 124	mg/dL

1 to 10 of 17Source ClinicalTrials.gov

See all 17 results by group

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Gusperimus	45
Overall Study	COMPLETED	Gusperimus	38
Overall Study	NOT COMPLETED	Gusperimus	7

Source ClinicalTrials.gov

Adverse events30

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
other	Anaemia	Blood and lymphatic system disorders	Gusperimus	8	45
other	Leucopaenia	Blood and lymphatic system disorders	Gusperimus	17	45
other	Lower respiratory tract infection	Infections and infestations	Gusperimus	12	45
other	Upper respiratory tract infection	Infections and infestations	Gusperimus	9	45
other	Urinary tract infection	Infections and infestations	Gusperimus	6	45
other	Candida infection	Infections and infestations	Gusperimus	7	45
other	Injection site pain/pruritus	General disorders	Gusperimus	26	45
other	Injection site haemorrhage	General disorders	Gusperimus	8	45
other	Pain oral cavity/throat	Gastrointestinal disorders	Gusperimus	19	45
other	Dysgeusia	Nervous system disorders	Gusperimus	8	45

1 to 10 of 30Source ClinicalTrials.gov

See all 30 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Gusperimus
Total, other adverse events	Gusperimus	45	45
Total, serious adverse events	Gusperimus	17	45

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
12538745	BACKGROUND

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/NCT00530075

GET https://conductscience.org/api/trials/v1/NCT00530075/events?page=2

API reference For AI assistants