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| Name | Class |
|---|---|
| Brigham and Women's Hospital | OTHER |
| George Washington University | OTHER |
| Vanderbilt University | OTHER |
| University of Washington |
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The SPin-D Trial is a phase II randomized, double-blind, placebo-controlled, multi-center study of spironolactone (SPL) for patients with hemodialysis-dependent end-stage renal disease.
The primary objective of this study is to characterize the safety and tolerability of multiple doses of chronic SPL therapy compared with placebo in maintenance hemodialysis patients and to assess the feasibility of conducting a full-scale, mortality-powered trial of SPL. The effects of SPL compared with placebo on multiple cardiovascular efficacy parameters will also be analyzed. The primary efficacy parameter will be the change in the E' measurement on tissue Doppler echocardiography (TDI) as an index of diastolic function and a surrogate for myocardial fibrosis. Secondary cardiac parameters of interest that will be studied in the overall population or in sub-studies include heart rate variability, circulating markers of fibrosis, and coronary flow reserve (CFR) as an index of microvascular function. These parameters are designed to broaden insight into the potential effects of SPL on cardiac structure and function in individuals with dialysis-dependent ESRD and to assess the feasibility of conducting a full-scale, mortality-powered trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spironolactone 12.5 mg | Active Comparator | Participants will initiate treatment at 12.5 mg daily and continue at this dose for 36 weeks. |
|
| Spironolactone 25 mg | Active Comparator | Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for a total treatment time of 36 weeks. |
|
| Spironolactone 50 mg | Active Comparator | Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for 2 weeks, and increased to 50 mg daily for a total treatment time of 36 weeks. |
|
| Placebo | Placebo Comparator | Participants will be treated with placebo for 36 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spironolactone | Drug | The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety - Number of Participants With Serum Potassium >6.5 mEq/L | The number of participants who had serum potassium >6.5 mEq/L was assessed by treatment arm. | 0 - 40 weeks |
| Safety - Participants With Serious Hypotension | The number of participants experiencing serious hypotension, defined as hypotension requiring hospitalization or ED visit and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g. aortic dissection). | 0 - 40 weeks |
| Study Drug Tolerability | Tolerability is defined as number of participants who experienced permanent study drug discontinuation or dose reduction. | 0 - 36 weeks |
| Efficacy - Change in Mitral Annular E' Velocity | Change in mitral annular E' velocity measured using Tissue Doppler Index (TDI) echocardiography. Efficacy outcomes were considered exploratory with a goal of detecting signals rather than clearly demonstrating efficacy. | Baseline to 36 weeks |
| Feasibility of Conducting a Full-scale Mortality-powered Trial | An objective of this study is to assess the feasibility of conducting a full-scale mortality-powered trial. Feasibility assessed based on recruitment, dropout and loss to follow-up rates. | 0 - 40 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety - Number of Participants With Serious Hyperkalemia | Number of patients with serious hyperkalemia requiring hospitalization, emergency/unscheduled dialysis or resin therapy | 0 - 40 weeks |
| Safety - Hyperkalemia Requiring Adjustment in Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura M Dember, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The George Washington University | Washington D.C. | District of Columbia | 20037 | United States | ||
| Brigham and Women's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33586138 | Derived | Hasegawa T, Nishiwaki H, Ota E, Levack WM, Noma H. Aldosterone antagonists for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2021 Feb 15;2(2):CD013109. doi: 10.1002/14651858.CD013109.pub2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants will be treated with placebo for 36 weeks. Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks. |
| FG001 | Spironolactone 12.5 mg | Participants will initiate treatment at 12.5 mg daily and continue at this dose for 36 weeks. Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks. |
| FG002 | Spironolactone 25 mg | Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for a total treatment time of 36 weeks. Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks. |
| FG003 | Spironolactone 50 mg | Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for 2 weeks, and increased to 50 mg daily for a total treatment time of 36 weeks. Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants were enrolled from dialysis units affiliated with four U.S. academic medical centers. The Institutional Review Boards affiliated with the clinical centers and with the data coordinating center approved the protocol and all participants provided informed consent.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants will be treated with placebo for 36 weeks. Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Safety - Number of Participants With Serum Potassium >6.5 mEq/L | The number of participants who had serum potassium >6.5 mEq/L was assessed by treatment arm. | Posted | Count of Participants | Participants | 0 - 40 weeks |
|
Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form.
Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants will be treated with placebo for 36 weeks. Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura M. Dember, MD | University of Pennsylvania | 215-573-5264 | ldember@pennmedicine.upenn.edu |
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| 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 | May 9, 2016 | Feb 19, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D013148 | Spironolactone |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 |
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| OTHER |
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|
Hyperkalemia requiring adjustment in dialysate potassium concentration, or discontinuation of study medication
| 0 - 40 weeks |
| Safety - Inter- or Intra-dialytic Hypotension | Inter- or intra-dialytic hypotension defined as:
| 0 - 40 weeks |
| Safety - Cardiovascular Death | Number of Cardiovascular deaths defined as death due to myocardial infarction, congestive heart failure, cardiac valvular disease, arrhythmia, sudden death, stroke, or peripheral arterial disease | 0 - 40 weeks |
| Efficacy - Secondary Cardiac Outcome Measure - Left Ventricular Ejection Fraction (LVEF) | Secondary outcome measures include other echocardiographic markers of systolic and diastolic function • Change in left ventricular ejection fraction between Baseline and 36 weeks | Baseline - 36 weeks |
| Efficacy - Secondary Cardiac Outcome Measures Left Ventricular Mass Index (LVMI) | Secondary outcome measures include other echocardiographic markers of systolic and diastolic function, • Change in left ventricular mass index (LVMI) between baseline and 36 weeks | Baseline - 36 weeks |
| Efficacy - Secondary Cardiac Outcome Measures - Ratio of Mitral Peak Velocity to Diastolic Mitral Annular Velocity (E/E') | Secondary outcome measures include other echocardiographic markers of systolic and diastolic function, • E/E' is the ratio of mitral peak velocity of early filling (E) to early diastolic mitral annular velocity (E') | Baseline - 36 weeks |
| Efficacy - Secondary Cardiac Outcome Measures - Left Ventricular Global Longitudinal Strain (LVGLS) | Secondary outcome measures include other echocardiographic markers of systolic and diastolic function, • Change in myocardial strain and strain rate between baseline and 36 weeks | Baseline - 36 weeks |
| Safety - Combined Incidence of Potassium >6.5 mEq/L or Serious Hyperkalemia | The number of participants who had serum potassium >6.5 mEq/L or serious hyperkalemia was assessed by treatment arm. | 0 - 40 Weeks |
| Boston |
| Massachusetts |
| 02120 |
| United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Kidney Research Institute, University of Washington | Seattle | Washington | 98104 | United States |
| Change to peritoneal dialysis |
|
| Transfer to non-participating unit |
|
| Dialysis discontinuation |
|
| Death |
|
| BG001 | Spironolactone 12.5 mg | Participants will initiate treatment at 12.5 mg daily and continue at this dose for 36 weeks. Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks. |
| BG002 | Spironolactone 25 mg | Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for a total treatment time of 36 weeks. Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks. |
| BG003 | Spironolactone 50 mg | Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for 2 weeks, and increased to 50 mg daily for a total treatment time of 36 weeks. Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG002 | Spironolactone 25 mg | Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for a total treatment time of 36 weeks. Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks. |
| OG003 | Spironolactone 50 mg | Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for 2 weeks, and increased to 50 mg daily for a total treatment time of 36 weeks. Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks. |
|
|
| Primary | Safety - Participants With Serious Hypotension | The number of participants experiencing serious hypotension, defined as hypotension requiring hospitalization or ED visit and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g. aortic dissection). | Posted | Count of Participants | Participants | 0 - 40 weeks |
|
|
|
| Primary | Study Drug Tolerability | Tolerability is defined as number of participants who experienced permanent study drug discontinuation or dose reduction. | Posted | Count of Participants | Participants | 0 - 36 weeks |
|
|
|
| Primary | Efficacy - Change in Mitral Annular E' Velocity | Change in mitral annular E' velocity measured using Tissue Doppler Index (TDI) echocardiography. Efficacy outcomes were considered exploratory with a goal of detecting signals rather than clearly demonstrating efficacy. | The number of participants analyzed reflects those who had analyzable echocardiogram data at both study time points. | Posted | Mean | Standard Deviation | cm/second | Baseline to 36 weeks |
|
|
|
| Primary | Feasibility of Conducting a Full-scale Mortality-powered Trial | An objective of this study is to assess the feasibility of conducting a full-scale mortality-powered trial. Feasibility assessed based on recruitment, dropout and loss to follow-up rates. | Posted | Count of Participants | Participants | 0 - 40 weeks |
|
|
|
| Secondary | Safety - Number of Participants With Serious Hyperkalemia | Number of patients with serious hyperkalemia requiring hospitalization, emergency/unscheduled dialysis or resin therapy | Posted | Count of Participants | Participants | 0 - 40 weeks |
|
|
|
| Secondary | Safety - Hyperkalemia Requiring Adjustment in Treatment | Hyperkalemia requiring adjustment in dialysate potassium concentration, or discontinuation of study medication | Posted | Count of Participants | Participants | 0 - 40 weeks |
|
|
|
| Secondary | Safety - Inter- or Intra-dialytic Hypotension | Inter- or intra-dialytic hypotension defined as:
| Posted | Count of Participants | Participants | 0 - 40 weeks |
|
|
|
| Secondary | Safety - Cardiovascular Death | Number of Cardiovascular deaths defined as death due to myocardial infarction, congestive heart failure, cardiac valvular disease, arrhythmia, sudden death, stroke, or peripheral arterial disease | Posted | Count of Participants | Participants | 0 - 40 weeks |
|
|
|
| Secondary | Efficacy - Secondary Cardiac Outcome Measure - Left Ventricular Ejection Fraction (LVEF) | Secondary outcome measures include other echocardiographic markers of systolic and diastolic function • Change in left ventricular ejection fraction between Baseline and 36 weeks | The number of participants analyzed reflects those who had analyzable echocardiogram data at both study time points. | Posted | Mean | Standard Deviation | percent ejection fraction | Baseline - 36 weeks |
|
|
|
| Secondary | Efficacy - Secondary Cardiac Outcome Measures Left Ventricular Mass Index (LVMI) | Secondary outcome measures include other echocardiographic markers of systolic and diastolic function, • Change in left ventricular mass index (LVMI) between baseline and 36 weeks | The number of participants analyzed reflects those who had analyzable echocardiogram data at both study time points. | Posted | Mean | Standard Deviation | g/m^2 | Baseline - 36 weeks |
|
|
|
| Secondary | Efficacy - Secondary Cardiac Outcome Measures - Ratio of Mitral Peak Velocity to Diastolic Mitral Annular Velocity (E/E') | Secondary outcome measures include other echocardiographic markers of systolic and diastolic function, • E/E' is the ratio of mitral peak velocity of early filling (E) to early diastolic mitral annular velocity (E') | The number of participants analyzed reflects those who had analyzable echocardiogram data at both study time points. | Posted | Mean | Standard Deviation | ratio | Baseline - 36 weeks |
|
|
|
| Secondary | Efficacy - Secondary Cardiac Outcome Measures - Left Ventricular Global Longitudinal Strain (LVGLS) | Secondary outcome measures include other echocardiographic markers of systolic and diastolic function, • Change in myocardial strain and strain rate between baseline and 36 weeks | The number of participants analyzed reflects those who had analyzable echocardiogram data at both study time points. | Posted | Mean | Standard Deviation | % of myocardial shortening | Baseline - 36 weeks |
|
|
|
| Secondary | Safety - Combined Incidence of Potassium >6.5 mEq/L or Serious Hyperkalemia | The number of participants who had serum potassium >6.5 mEq/L or serious hyperkalemia was assessed by treatment arm. | Posted | Count of Participants | Participants | 0 - 40 Weeks |
|
|
|
| 2 |
| 51 |
| 27 |
| 51 |
| 45 |
| 51 |
| EG001 | Spironolactone 12.5 mg | Participants will initiate treatment at 12.5 mg daily and continue at this dose for 36 weeks. Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks. | 0 | 27 | 13 | 27 | 24 | 27 |
| EG002 | Spironolactone 25 mg | Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for a total treatment time of 36 weeks. Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks. | 2 | 26 | 13 | 26 | 25 | 26 |
| EG003 | Spironolactone 50 mg | Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for 2 weeks, and increased to 50 mg daily for a total treatment time of 36 weeks. Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks. | 1 | 25 | 12 | 25 | 23 | 25 |
| Acute MI, atrial fibrillation, bradycardia, palpitations | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain, diarrhea, GI hemorrhage, nausea, vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Asthenia, chest pain | General disorders | MedDRA | Systematic Assessment |
|
| Hemobilia, hepatic cirrhosis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Bacteremia, influenza, osteomyelitis, pneumonia. sepsis, skin graft infection, UTI, viral infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| AVfistula site hemorrhage, vascular access complications, fall, laceration, rib fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Cardiac catheterisation, fistulogram, pleural biopsy | Investigations | MedDRA | Systematic Assessment |
|
| Hyperkalemia, hypocalcemia, fluid overload | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Arthralgia, back pain, neck pain, extremity pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Gastric cancer, renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Balance disorder, dementia, headache, paralysis, syncope | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Anxiety, depression, mental status changes | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Bladder mass, hematuria, urinary retention | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Asthma, COPD, cough , dyspnea, pleural effusion, stridor | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Blister, erythema, pruritus | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Angioplasty, catheter placement, toe amputation, renal transplant, thrombectomy, nephrectomy | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Hypertension, hypotension, thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| Hyperparathyroidism | Endocrine disorders | MedDRA | Systematic Assessment |
|
| Blurred vision | Eye disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain, nausea, diarrhea, constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Pain, peripheral edema, malaise | General disorders | MedDRA | Systematic Assessment |
|
| Bronchitis, diverticulitis, cystitis, cellulitis, naspharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Fall, rib fracture, vascular graft complication | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Skin biopsy, liver biopsy, low hemoglobin | Investigations | MedDRA | Systematic Assessment |
|
| Hyperkalemia, hyperphosphatemia, hypercalcemia, gout | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Arthralgia, arthritis, osteoarthritis, tendonitis, neck pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Dizziness, headache, migraine, tremor, syncope | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Dysuria, hematuria, incontinence | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Breast tenderness, enlargement | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| COPD, pleural effusion, asthma, cough, dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pruritis, rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| AV fistula, thrombectomy, catheter placement, stent placment, amputation, vascular operation | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
|
Not provided
Not provided
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| 36 Week MA E' |
|
| Change between baseline - 36 weeks |
|
| Change to peritoneal dialysis |
|
| Transfer to non-participating facility |
|
| Dialysis discontinued |
|
| Death |
|
| Study completed |
|
| Intra-dialytic hypotension only |
|
| Inter- & intra-dialytic hypotension |
|
| No inter- or intra-dialytic hypotension |
|
| LVEF 36-Week |
|
| LVEF Change |
|
| LVMI 36-Week |
|
| LVMI Change |
|
| E/E' 36-Week |
|
| E/E' Change |
|
| LVGLS 36-week |
|
| LVGLS Change |
|