30 closest matches · ranked by relevance
Improve Endothelial Function and Decrease Vascular Stenosis
Primary: Change in Baseline and 2 Week FMD/VP Measurements Between Sildenafil Group and Placebo Group — 10.8; 8.6 Change in FMD%
End Stage Renal Disease on Hemodialysis (Diagnosis)
Primary: Percentage of Subjects Reporting Clinically Significant Adverse Events - Medically-attended Adverse Events, Serious Adverse Events, and Immune-mediated Adverse Events of…
Chronic Kidney Disease · Secondary Hyperparathyroidism
Primary: Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26) — 96; 58; 57; 93 participants — p=<0.0001
Anemia · End Stage Renal Disease (ESRD)
Primary: Change From Baseline (BL) to the Average Hemoglobin (Hb) in Weeks 28-36 Without Rescue Therapy [EU (EMA)] — 0.428; 0.193 g/dL — p=<0.001
End Stage Renal Disease · Anemia
Primary: Number of Participants With Week 7 Hb ≥ Baseline Hb - 0.5 g/dL, Among Normoresponder Participants Treated for 6 Weeks Only — 4; 8; 7; 4 Participants — p=1.0000
Diabetes · Diabetes Mellitus, Type 1 · Diabetes Mellitus, Type 2
Primary: Mean Absolute Relative Difference Between CGM Value and Capillary Blood Glucose (Self-monitoring Blood Glucose [SMBG]) — 13.8 percent difference
End Stage Renal Disease
Primary: Reduction Ratio of Lambda Immunoglobulin FLC at Week 24 — 32.156; 17.514 percentage ratio
End-Stage Renal Disease (ESRD)
Primary: Number of Participants With Adverse Events (AEs) — 8 participants
Hemodialysis · Kidney Failure, Chronic
Primary: QOL: Kidney Disease Quality of Life (KDQOL36) — 74; 72 score on a scale
End Stage Renal Disease · Thrombosis
Primary: The Number of Subjects With Treatment-related Adverse Events (TEAEs) and the Number of TEAEs Will be Summarized Using Frequency Counts (Safety and Tolerability) — 0; 0…
End Stage Renal Failure on Dialysis
Primary: Patients' Adherence to Study Protocol — 22; 24; 19; 19 Participants
End-Stage Renal Disease (ESRD)
Primary: Percent of Subjects Whose Hemoglobin (Hgb) Decreases by a Total of 1.0 Grams/ Deciliter (g/dL) (or More) From Baseline on Each of Two Successive Measurements. — 5; 6; 5…
Chronic Renal Anemia
Primary: Time to Composite of All-Cause Mortality and Non-Fatal Cardiovascular Events (Myocardial Infarction, Stroke) Defined as Time Between First Dose of Study Medication and…
ESRD
Primary: Change in Leucine Disposal Rate (LDR) — -0.011; 0.005; 0.001 mg/kg/min — p=0.37
Anemia
Primary: Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 2 (Month 1) — 23 participants
Hyperkalemia
Primary: Incidence of Pre-dialysis HK After the LIDP in <3K Dialysate Patients — 50; 37 Percent of participants
Chronic Kidney Disease
Primary: Maximal Oxygen Uptake — 14.5; 15.1 ml/kg/min
Chronic Kidney Diseases · Patient Requiring Heparin Free Dialysis Treatments
Primary: The Primary Endpoint is the Number and Percent (%) of Successful Heparin-free HD Sessions for Each Subject in Each Circuit. — 2.4; 2.9 number of successful HD sessions
Chronic Kidney Disease
Primary: Preference for Shared Decision Making — 22; 19; 35; 44 participants
End-Stage Renal Disease
Primary: Primary Safety Endpoint — 16.1; 11.6 Adverse Events per 100 Treatments
Chronic Kidney Disease
Primary: Mortality — 0; 0 percentage of mortality
End-stage Renal Disease (ESRD)
Primary: Number of Participants With Major Bleeding (MB) and Clinically Relevant Non-Major Bleeding (CRNMB) — 3; 2; 3; 3 Participants
Anemia in Incident Dialysis Patients
Primary: US (FDA) Submission: Mean Hb Change From Baseline to The Average Level During The Evaluation Period (Week 28 to Week 52), Regardless of Rescue Therapy (ITT Population)…
Hypertension · End Stage Renal Disease
Primary: Change in Mean Interdialytic 44-hour Ambulatory Systolic Blood Pressure Over a 2 Week Follow-up Period — -1.5; -3.7; -0.4 mm Hg
Depression · Hemodialysis-Induced Symptom
Primary: To Determine the Impact of Directly Observed Weekly Fluoxetine Treatment on Remission of Depression Among Hemodialysis Patients. — 6.6 units on a scale
End Stage Kidney Disease
Primary: Percent of Time in Range (TIR) Between 70-180 mg/dL — 80.4; 94.0 percentage of time
Antithrombotic
Primary: The Number of Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation and Death — 4; 4; 3; 2 Participants
Renal Insufficiency, Chronic
Primary: Number of Participants With Sufficient Patency for Clinical Access — 20 Participants
Chronic Kidney Disease
Primary: Factors That Are Most Important to Patients — 98; 93; 97; 100 % of patients
Anemia · End Stage Renal Disease
Primary: Change From Pre-dose Average in Hemoglobin (Hgb) Level to The Mid-study Average — 10.43; 10.55; 10.52; 0.00 Grams per deciliter (g/dL)