| ID | Type | Description | Link |
|---|---|---|---|
| R01FD00351604 | Other Grant/Funding Number | Food and Drug Administration (FDA) | |
| 2009-013220-24 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Cambridge University Hospitals NHS Foundation Trust | OTHER |
| University of Birmingham | OTHER |
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine whether plasma exchange as well as immunosuppressive therapy are effective in reducing death and end-stage renal disease (ESRD). The trial will also study whether a reduced cumulative dosing regimen of glucocorticoids is as effective as a standard disease regimen.
The FDA-OOPD is one of the funding sources for this study.
Granulomatosis with polyangiitis (Wegener's) (WG) and microscopic polyangiitis (MPA) are syndromes of primary systemic vasculitis associated with anti-neutrophil cytoplasm antibodies (ANCA). Together, these syndromes are grouped as ANCA-associated systemic vasculitis (AAV).
Plasma exchange, a method of rapidly removing potentially pathogenic ANCA and other mediators of inflammation and coagulation, has shown promise as an adjunctive therapy in AAV to improve early disease control and improve rates of renal recovery in severe disease. Glucocorticoids (steroids) are a standard of care in the treatment of AAV. High doses of glucocorticoids early in disease, although reduce disease activity due to their anti-inflammatory and immunosuppressive properties, also increase the risk of infection, particularly in the elderly and in the presence of uremia. There is no randomized trial data to guide glucocorticoids dosing.
Patients with severe new or relapsing AAV and pulmonary hemorrhage and/or renal disease will be eligible for this trial.
Subjects participating in this study will be randomized to receive one of the following groups;
All studies will receive standard remission-induction therapy with either cyclophosphamide or rituximab.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plasma Exchange with Standard Glucocorticoids | Experimental | Participants in this arm undergo plasma exchange and take a standard glucocorticoid dose. |
|
| No Plasma Exchange with Standard Glucocorticoids | Active Comparator | Participants in this arm do not undergo plasma exchange and take a standard glucocorticoid dose. |
|
| Plasma Exchange with Reduced-Dose Glucocorticoids | Experimental | Participants in this arm undergo plasma exchange and take a reduced glucocorticoid dose. |
|
| No Plasma Exchange with Reduced-Dose Glucocorticoids | Active Comparator | Participants in this arm do not undergo plasma exchange and take a reduced glucocorticoid dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plasma Exchange | Procedure | Plasma exchange is a procedure whereby blood is taken from the body and separated by a machine into blood cells and plasma, which is the liquid part of blood. The plasma is discarded and the blood cells are returned to the body with a plasma substitute. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of i) All-cause Mortality or ii) End-stage Renal Disease | 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. | Time frame varied by subject: minimum of 1 year - maximum of 7 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Sustained Remission | Remission that occurs before 6 months, and lasts without a first relapse until at least 12 months after randomization | Time frame varied by subject: minimum of 1 year - maximum of 7 years |
| Rate of Serious Infection Events |
Not provided
Inclusion Criteria:
• New or previous clinical diagnosis of granulomatosis with polyangiitis or microscopic polyangiitis consistent with the Chapel-Hill consensus definitions
AND
• Positive test for proteinase 3-ANCA or myeloperoxidase-ANCA
AND
Severe vasculitis defined by at least one of the following:
Renal involvement characterized by both of the following:
AND
Pulmonary hemorrhage due to active vasculitis defined by:
AND
AND
At least one of the following:
Provision of informed consent by patient or a surrogate decision maker
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David Jayne, MD | Cambridge University Hospitals NHS Foundation Trust | Principal Investigator |
| Peter Merkel, MD, MPH | University of Pennsylvania | Principal Investigator |
| Michael Walsh, MD | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States | ||
| Boston University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23497590 | Background | Walsh M, Merkel PA, Peh CA, Szpirt W, Guillevin L, Pusey CD, De Zoysa J, Ives N, Clark WF, Quillen K, Winters JL, Wheatley K, Jayne D; PEXIVAS Investigators. Plasma exchange and glucocorticoid dosing in the treatment of anti-neutrophil cytoplasm antibody associated vasculitis (PEXIVAS): protocol for a randomized controlled trial. Trials. 2013 Mar 14;14:73. doi: 10.1186/1745-6215-14-73. | |
| 32053298 |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
704 subjects were enrolled into the study and randomized to either plasma exchange or no plasma exchange, and randomized to receive either standard dose GC or reduced dose GC.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Plasma Exchange With Standard Glucocorticoids | Plasma Exchange: Plasma exchange is a procedure whereby blood is taken from the body and separated by a machine into blood cells and plasma, which is the liquid part of blood. The plasma is discarded and the blood cells are returned to the body with a plasma substitute. Glucocorticoids: During the study, a standard glucocorticoids dose regimen will be compared to a reduced glucocorticoids dose regimen. All subjects' patients will receive the same glucocorticoids dose for the first two weeks then will follow a standard regimen. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 19, 2015 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| No Plasma Exchange | Other | No plasma exchange. |
|
| Glucocorticoids [Standard Dose] | Drug | During the study, a standard glucocorticoids dose regimen will be compared to a reduced glucocorticoids dose regimen. All subjects' patients will receive the same glucocorticoids dose for the first two weeks then the dose will decrease following a standard regimen. |
|
| Glucocorticoids [Reduced Dose] | Drug | During the study, a standard glucocorticoids dose regimen will be compared to a reduced glucocorticoids dose regimen. All subjects' patients will receive the same glucocorticoids dose for the first two weeks then the dose will decrease following a reduced regimen. |
|
Serious infections defined as an infectious syndrome that requires intravenous antibiotics or hospitalization for treatment. |
| Time frame varied by subject: minimum of 1 year - maximum of 7 years |
| Health-related Quality of Life Using the SF-36 Physical Composite | 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. | 12 months |
| Health-related Quality of Life Using the SF-36 Mental Composite | 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. | 12 months |
| Health-related Quality of Life Using the EQ-5D Index Descriptive System | 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. | 12 months |
| Boston |
| Massachusetts |
| 02118 |
| United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Washington University School of Medicine | St Louis | Missouri | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| University of Virginia | Charlottesville | Virginia | 22904 | United States |
| Canberra Hospital | Garran | Australian Capital Territory | Australia |
| Concord Repatriation General Hospital | Concord | New South Wales | Australia |
| John Hunter Hospital, | New Lambton Heights | New South Wales | Australia |
| Prince of Wales Hospital | Randwick | New South Wales | Australia |
| Royal North Shore Hospital | St Leonards | New South Wales | Australia |
| Royal Brisbane and Women's Hospital | Herston | Queensland | Australia |
| Nambour Hospital | Nambour | Queensland | Australia |
| Princess Alexandra Hospital | Woolloongabba | Queensland | Australia |
| Flinders Medical Centre, | Adelaide | South Australia | Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | Australia |
| Royal Hobart Hospital | Hobart | Tasmania | Australia |
| Monash Medical Centre | Clayton | Victoria | Australia |
| St Vincent's Hospital | Fitzroy | Victoria | Australia |
| The Geelong Hospital | Geelong | Victoria | Australia |
| Austin Hospital | Heidelberg | Victoria | Australia |
| The Royal Melbourne Hospital | Parkville | Victoria | Australia |
| Fremantle Hospital, | Fremantle | Western Australia | Australia |
| Gold Coast Hospital | Southport | Australia |
| University Hospitals Leuven | Leuven | Belgium |
| University of Calgary | Calgary | Alberta | Canada |
| University of Alberta | Edmonton | Alberta | Canada |
| St Paul's Hospital | Vancouver | British Columbia | Canada |
| St Joseph's Hospital | Hamilton | Ontario | Canada |
| London Health Sciences Centre | London | Ontario | Canada |
| The Ottawa Hospital | Ottawa | Ontario | Canada |
| Mount Sinai Hospital | Toronto | Ontario | Canada |
| St Michael's Hospital | Toronto | Ontario | Canada |
| Hopital Saint-Luc | Montreal | Quebec | H2X 3J4 | Canada |
| General Faculty Hospital | Prague | Czechia |
| Aarhus University Hospital | Aarhus | Denmark |
| Herlev Hospital | Copenhagen | Denmark |
| Rigshospitalet | Copenhagen | Denmark |
| Holstebro Hospital and University of Aarhus | Holstebro | Denmark |
| Centre Hospitalier de Boulogne | Boulogne-sur-Mer | France |
| CHRU Brest Hopital La Cavale Blanche | Brest | France |
| CHU Brest | Brest | France |
| CHU Caen - Nephrology Department | Caen | France |
| CHU Clermont-Ferrand | Clermont-Ferrand | France |
| Colmar Hospital - Nephrology | Colmar | France |
| CHU D'Angers | D'Angers | France |
| Centre Hospitalier Universitaire de Grenoble | Grenoble | France |
| Hopital Site Sainte Blandine | Metz | France |
| Centre Hospitalier de Mulhouse | Mulhouse | France |
| Hopital Bichat Claude Bernard | Paris | France |
| Hopital Cochin | Paris | France |
| Hopital Europeen Georges-Pompidou | Paris | France |
| Centre Hospitalier de la Region d'Annecy | Pringy | France |
| CHU De Toulouse-Hotel Dieu Saint Jacques | Toulouse | France |
| CHU Hopital Bretonneau | Tours | France |
| Centre Hospitalier de Valenciennes | Valenciennes | France |
| Hippokration Hospital | Thessaloniki | Greece |
| University of Brescia | Brescia | Italy |
| Azienda Ospedaliero Universitaria di Parma | Parma | Italy |
| University of Tsukuba | Tsukuba | Ibaraki | 305-8572 | Japan |
| Kyoto University Hospital | Kyoto | 606-8507 | Japan |
| University of Miyazaki Hospital | Miyazaki | Japan |
| Kitano Hospital | Osaka | Japan |
| Teikyo University Hospital | Tokyo | Japan |
| Tokyo Metropolitan Geriatric Hospital | Tokyo | Japan |
| Instituto Nacional de Enfermedades Respiratorias | Mexico City | Mexico |
| North Shore Hospital | Takapuna | Auckland | New Zealand |
| Dunedin Hospital | Dunedin | New Zealand |
| Waikato Hospital | Hamilton | 3204 | New Zealand |
| University Hospital North Norway HF | Tromsø | Norway |
| St Olavs Hospital, Trondheim University Hospital | Trondheim | Norway |
| Linkoping University Hospital | Linköping | Sweden |
| Skane University Hospital | Malmö | Sweden |
| Karolinska Institute | Stockholm | Sweden |
| Western Infirmary | Glasgow | Scotland | United Kingdom |
| Aberdeen Royal Infirmary | Aberdeen | AB25 2 | United Kingdom |
| Queen Elizabeth Hospital | Birmingham | B15 2TQ | United Kingdom |
| Brighton and Sussex University Hospitals | Brighton | BN2 5BE | United Kingdom |
| Addenbrooke's Hospital | Cambridge | CB22QQ | United Kingdom |
| Kent and Canterbury Hospital | Canterbury | United Kingdom |
| University Hospitals Coventry and Warwickshire NHS Trust | Coventry | CV2 2DX | United Kingdom |
| Royal Infirmary of Edinburgh | Edinburgh | EH16 4SA | United Kingdom |
| Royal Devon & Exeter Hospital (Wonford) | Exeter | United Kingdom |
| St James's University Hospital | Leeds | United Kingdom |
| Royal Liverpool University Hospital | Liverpool | L7 8XP | United Kingdom |
| Royal Free Hospital | London | NW3 2QG | United Kingdom |
| The Royal London Hospital | London | SE1 2PR | United Kingdom |
| St. George's Hospital | London | SW17 0QT | United Kingdom |
| Hammersmith Hospital | London | W12 0HS | United Kingdom |
| Manchester Royal Infirmary | Manchester | United Kingdom |
| Freeman Hospital | Newcastle | United Kingdom |
| Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences | Oxford | OX3 7LD | United Kingdom |
| Churchill Hospital | Oxford | OX3 7LJ | United Kingdom |
| Royal Preston Hospital | Preston | PR2 9HT | United Kingdom |
| Royal Berkshire Hospital, Reading | Reading | RG1 5AQ | United Kingdom |
| Result |
| Walsh M, Merkel PA, Peh CA, Szpirt WM, Puechal X, Fujimoto S, Hawley CM, Khalidi N, Flossmann O, Wald R, Girard LP, Levin A, Gregorini G, Harper L, Clark WF, Pagnoux C, Specks U, Smyth L, Tesar V, Ito-Ihara T, de Zoysa JR, Szczeklik W, Flores-Suarez LF, Carette S, Guillevin L, Pusey CD, Casian AL, Brezina B, Mazzetti A, McAlear CA, Broadhurst E, Reidlinger D, Mehta S, Ives N, Jayne DRW; PEXIVAS Investigators. Plasma Exchange and Glucocorticoids in Severe ANCA-Associated Vasculitis. N Engl J Med. 2020 Feb 13;382(7):622-631. doi: 10.1056/NEJMoa1803537. |
| 38346237 | Derived | Fussner LA, Flores-Suarez LF, Cartin-Ceba R, Specks U, Cox PG, Jayne DRW, Merkel PA, Walsh M; PEXIVAS Investigators. Alveolar Hemorrhage in Antineutrophil Cytoplasmic Antibody-Associated Vasculitis: Results of an International Randomized Controlled Trial (PEXIVAS). Am J Respir Crit Care Med. 2024 May 1;209(9):1141-1151. doi: 10.1164/rccm.202308-1426OC. |
| 36155131 | Derived | Jayne D, Walsh M, Merkel PA, Peh CA, Szpirt W, Puechal X, Fujimoto S, Hawley C, Khalidi N, Jones R, Flossmann O, Wald R, Girard L, Levin A, Gregorini G, Harper L, Clark W, Pagnoux C, Specks U, Smyth L, Ito-Ihara T, de Zoysa J, Brezina B, Mazzetti A, McAlear CA, Reidlinger D, Mehta S, Ives N, Brettell EA, Jarrett H, Wheatley K, Broadhurst E, Casian A, Pusey CD. Plasma exchange and glucocorticoids to delay death or end-stage renal disease in anti-neutrophil cytoplasm antibody-associated vasculitis: PEXIVAS non-inferiority factorial RCT. Health Technol Assess. 2022 Sep;26(38):1-60. doi: 10.3310/PNXB5040. |
| Related Info | View source |
| FG001 | Plasma Exchange With Reduced Glucocorticoids | Plasma Exchange: Plasma exchange is a procedure whereby blood is taken from the body and separated by a machine into blood cells and plasma, which is the liquid part of blood. The plasma is discarded and the blood cells are returned to the body with a plasma substitute. Glucocorticoids: During the study, a standard glucocorticoids dose regimen will be compared to a reduced glucocorticoids dose regimen. All subjects' patients will receive the same glucocorticoids dose for the first two weeks then the dose will decrease to a reduced regimen. |
| FG002 | No Plasma Exchange With Standard Glucocorticoids | Participants in this arm do not undergo plasma exchange. Glucocorticoids: During the study, a standard glucocorticoids dose regimen will be compared to a reduced glucocorticoids dose regimen. All subjects' patients will receive the same glucocorticoids dose for the first two weeks then follow a standard regimen. |
| FG003 | No Plasma Exchange With Reduced Glucocorticoid | Participants in this arm do not undergo plasma exchange. All subjects' received the same glucocorticoids dose for the first two weeks, then the dose was decreased following a reduced glucocorticoid dose regimen. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Plasma Exchange | Plasma Exchange: Plasma exchange is a procedure whereby blood is taken from the body and separated by a machine into blood cells and plasma, which is the liquid part of blood. The plasma is discarded and the blood cells are returned to the body with a plasma substitute. |
| BG001 | No Plasma Exchange | Participants in this arm do not undergo plasma exchange. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
| |||||||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
| |||||||||||||||
| ANCA Binding Specificity: PR3 | Count of Participants | Participants | No |
| |||||||||||||||
| ANCA Binding Specificity: MPO | Count of Participants | Participants |
| ||||||||||||||||
| Severity of Renal Disease at Presentation: Creatinine <500umol/min | Count of Participants | Participants | No |
| |||||||||||||||
| Severity of Renal Disease at Presentation: Requiring Dialysis or Creatinine >=500umol/min | Count of Participants | Participants | No |
|
| 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 | Composite of i) All-cause Mortality or ii) End-stage Renal Disease | 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. | Posted | Count of Participants | Participants | Time frame varied by subject: minimum of 1 year - maximum of 7 years |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Sustained Remission | Remission that occurs before 6 months, and lasts without a first relapse until at least 12 months after randomization | Posted | Count of Participants | Participants | Time frame varied by subject: minimum of 1 year - maximum of 7 years |
| ||||||||||||||||||||||||||||||||
| Secondary | Rate of Serious Infection Events | Serious infections defined as an infectious syndrome that requires intravenous antibiotics or hospitalization for treatment. | Posted | Number | events | Time frame varied by subject: minimum of 1 year - maximum of 7 years |
| ||||||||||||||||||||||||||||||||
| Secondary | Health-related Quality of Life Using the SF-36 Physical Composite | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 12 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Health-related Quality of Life Using the SF-36 Mental Composite | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 12 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Health-related Quality of Life Using the EQ-5D Index Descriptive System | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 12 months |
|
Adverse event data was collected from time of consent through study completion. The first subject was enrolled in June 2010, and the study completed in July 2017. Adverse event data was collected for 7 years and 1 month.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Plasma Exchange | Plasma Exchange: Plasma exchange is a procedure whereby blood is taken from the body and separated by a machine into blood cells and plasma, which is the liquid part of blood. The plasma is discarded and the blood cells are returned to the body with a plasma substitute. | 46 | 352 | 225 | 352 | 0 | 352 |
| EG001 | No Plasma Exchange | Participants in this arm do not undergo plasma exchange | 53 | 352 | 224 | 352 | 0 | 352 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiovascular | Cardiac disorders | Systematic Assessment |
| ||
| Endocrine | Endocrine disorders | Systematic Assessment |
| ||
| Gastrointestinal | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hematological | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Infection | Infections and infestations | Systematic Assessment |
| ||
| Renal | Renal and urinary disorders | Systematic Assessment |
| ||
| Surgery | Vascular disorders | Systematic Assessment |
| ||
| Vasculitis Relapse | Immune system disorders | Systematic Assessment |
| ||
| Other | General disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael Walsh | McMaster University, Hamilton, Ontario | 905-522-1155 | 34055 | lastwalsh1975@gmail.com |
| Oct 18, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D014890 | Granulomatosis with Polyangiitis |
| D055953 | Microscopic Polyangiitis |
| D014657 | Vasculitis |
| D056648 | Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D056647 | Systemic Vasculitis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D059345 | Cerebral Small Vessel Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D010951 | Plasma Exchange |
| D005938 | Glucocorticoids |
| ID | Term |
|---|---|
| D001803 | Blood Transfusion |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D010956 | Plasmapheresis |
| D001781 | Blood Component Removal |
| D016060 | Sorption Detoxification |
| D005112 | Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
Not provided
Not provided
| Male |
|
| Arab |
|
| Chinese |
|
| Japanese |
|
| Other Asian |
|
| Black African |
|
| Coloured African |
|
| Other Black |
|
| European |
|
| Latin America |
|
| Native N/S American or Aborigine |
|
| Other |
|
| Missing |
|
| Czechia |
|
| Japan |
|
| United Kingdom |
|
| New Zealand |
|
| Canada |
|
| Sweden |
|
| Belgium |
|
| Norway |
|
| Denmark |
|
| Italy |
|
| Mexico |
|
| Australia |
|
| France |
|
| Poland |
|
| Spain |
|
| Units | Counts |
|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
|
|