Trial · NCT00987389
Plasma Exchange and Glucocorticoids for Treatment of Anti-Neutrophil Cytoplasm Antibody (ANCA) - Associated Vasculitis
NCT00987389, Phase 3, Completed, University of Pennsylvania; results first posted 2020-05-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Plasma Exchange and Glucocorticoids for Treatment of Anti-Neutrophil Cytoplasm Antibody (ANCA) - Associated Vasculitis. Trials, record NCT00987389. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00987389
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Plasma Exchange and Glucocorticoids for Treatment of Anti-Neutrophil Cytoplasm Antibody (ANCA) - Associated Vasculitis
- NCT number
- NCT00987389
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 704 participants, actual
- Lead sponsor
- University of Pennsylvania
- Conditions
- Granulomatosis With Polyangiitis (Wegener's) (GPA), Microscopic Polyangiitis (MPA)
- Interventions
- Plasma Exchange, No Plasma Exchange, Glucocorticoids [Standard Dose], Glucocorticoids [Reduced Dose]
- First posted
- 2009-09-30
- Last updated
- 2020-05-26
- Other registries' IDs
- eudract:2009-013220-24
- Results first posted
- 2020-05-26
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Composite of i) All-cause Mortality or ii) End-stage Renal Disease | Time frame varied by subject: minimum of 1 year - maximum of 7 years | The primary outcome was a composite of death from any cause or end-stage renal disease (ESRD), defined as ≥12 continuous weeks of renal replacement therapy. |
| Secondary | Number of Participants With Sustained Remission | Time frame varied by subject: minimum of 1 year - maximum of 7 years | Remission that occurs before 6 months, and lasts without a first relapse until at least 12 months after randomization |
| Secondary | Rate of Serious Infection Events | Time frame varied by subject: minimum of 1 year - maximum of 7 years | Serious infections defined as an infectious syndrome that requires intravenous antibiotics or hospitalization for treatment. |
| Secondary | Health-related Quality of Life Using the SF-36 Physical Composite | 12 months | Quality of life was measured using the 36-item Short Form (SF-36) physical composite scores. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life. |
| Secondary | Health-related Quality of Life Using the SF-36 Mental Composite | 12 months | Quality of life was measured using the 36-item Short Form (SF-36) mental composite scores. Scores for the scale range from 0-100 and transformed to have a mean of 50 and SD of 10 in the reference population, with higher scores indicating a better Health-related Quality of Life. |
| Secondary | Health-related Quality of Life Using the EQ-5D Index Descriptive System | 12 months | EuroQoL-5 Dimensions consist of 2 elements: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprised of following 5 dimensions: 1.Mobility, 2.Self-Care, 3.Usual Activities, 4.Pain/Discomfort and 5.Anxiety/Depression. Each of these 5 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The digits for each of 5 dimensions were combined in a 5-digit number describing the participant's health state: e.g. state 11111 indicates no problem on any of the 5 dimensions. Health state index scores generally range from less than 0 (where 0 is a health state equivalent to death; negative values are valued as worse than death) to 1 (perfect health), with higher scores indicating higher health utility. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Composite of i) All-cause Mortality or ii) End-stage Renal Disease | Time frame varied by subject: minimum of 1 year - maximum of 7 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Sustained Remission | Time frame varied by subject: minimum of 1 year - maximum of 7 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Rate of Serious Infection Events | Time frame varied by subject: minimum of 1 year - maximum of 7 years | events | NUMBER | |
| SECONDARY | Health-related Quality of Life Using the SF-36 Physical Composite | 12 months | units on a scale | MEAN | |
| SECONDARY | Health-related Quality of Life Using the SF-36 Mental Composite | 12 months | score on a scale | MEAN | |
| SECONDARY | Health-related Quality of Life Using the EQ-5D Index Descriptive System | 12 months | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Composite of i) All-cause Mortality or ii) End-stage Renal Disease | Plasma Exchange | 100 | Participants | ||
| Composite of i) All-cause Mortality or ii) End-stage Renal Disease | No Plasma Exchange | 109 | Participants | ||
| Number of Participants With Sustained Remission | Plasma Exchange | 200 | Participants | ||
| Number of Participants With Sustained Remission | No Plasma Exchange | 197 | Participants | ||
| Rate of Serious Infection Events | Plasma Exchange | 145 | events | ||
| Rate of Serious Infection Events | No Plasma Exchange | 132 | events | ||
| Health-related Quality of Life Using the SF-36 Physical Composite | Plasma Exchange | 39.04 | 95% Confidence Interval 38.58 to 41.65 | units on a scale | |
| Health-related Quality of Life Using the SF-36 Physical Composite | No Plasma Exchange | 37.96 | 95% Confidence Interval 37.5 to 40.57 | units on a scale | |
| Health-related Quality of Life Using the SF-36 Mental Composite | Plasma Exchange | 51.94 | 95% Confidence Interval 51.27 to 53.70 | score on a scale | |
| Health-related Quality of Life Using the SF-36 Mental Composite | No Plasma Exchange | 51.40 | 95% Confidence Interval 50.73 to 53.16 | score on a scale |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Plasma Exchange With Standard Glucocorticoids | 176 | |
| Overall Study | STARTED | Plasma Exchange With Reduced Glucocorticoids | 176 | |
| Overall Study | STARTED | No Plasma Exchange With Standard Glucocorticoids | 175 | |
| Overall Study | STARTED | No Plasma Exchange With Reduced Glucocorticoid | 177 | |
| Overall Study | COMPLETED | Plasma Exchange With Standard Glucocorticoids | 167 | |
| Overall Study | COMPLETED | Plasma Exchange With Reduced Glucocorticoids | 168 | |
| Overall Study | COMPLETED | No Plasma Exchange With Standard Glucocorticoids | 167 | |
| Overall Study | COMPLETED | No Plasma Exchange With Reduced Glucocorticoid | 174 | |
| Overall Study | NOT COMPLETED | Plasma Exchange With Standard Glucocorticoids | 9 | |
| Overall Study | NOT COMPLETED | Plasma Exchange With Reduced Glucocorticoids | 8 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events18
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 |
|---|---|---|---|---|---|---|
| serious | Cardiovascular | Cardiac disorders | Plasma Exchange | 69 | 352 | |
| serious | Cardiovascular | Cardiac disorders | No Plasma Exchange | 55 | 352 | |
| serious | Endocrine | Endocrine disorders | Plasma Exchange | 9 | 352 | |
| serious | Endocrine | Endocrine disorders | No Plasma Exchange | 2 | 352 | |
| serious | Gastrointestinal | Gastrointestinal disorders | Plasma Exchange | 34 | 352 | |
| serious | Gastrointestinal | Gastrointestinal disorders | No Plasma Exchange | 39 | 352 | |
| serious | Hematological | Blood and lymphatic system disorders | Plasma Exchange | 25 | 352 | |
| serious | Hematological | Blood and lymphatic system disorders | No Plasma Exchange | 16 | 352 | |
| serious | Infection | Infections and infestations | Plasma Exchange | 136 | 352 | |
| serious | Infection | Infections and infestations | No Plasma Exchange | 114 | 352 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Plasma Exchange | 46 | 352 |
| Total, all-cause mortality | No Plasma Exchange | 53 | 352 |
| Total, other adverse events | Plasma Exchange | 0 | 352 |
| Total, other adverse events | No Plasma Exchange | 0 | 352 |
| Total, serious adverse events | Plasma Exchange | 225 | 352 |
| Total, serious adverse events | No Plasma Exchange | 224 | 352 |
Source ClinicalTrials.gov
Papers4
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Plasma Exchange vs No Plasma Exchange: Number of Participants With Sustained Remission | Trial comparisons |
| Plasma Exchange vs No Plasma Exchange: Composite of i) All-cause Mortality or ii) End-stage Renal Disease | Trial comparisons |
| Plasma Exchange vs No Plasma Exchange: deaths from any cause | Trial comparisons |
| Plasma Exchange vs No Plasma Exchange: serious adverse events | Trial comparisons |
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/NCT00987389
GET https://conductscience.org/api/trials/v1/NCT00987389/registered