Phase 2 N=14 Phase 2 Study With SNF472 in Calciphylaxis Patients
Calciphylaxis · Calcific Uremic Arteriolopathy
Primary: Wound Healing — -8.1 units on a scale — p=<0.001
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Phase 3 N=71 Phase 3 Study of SNF472 for Calciphylaxis
Calciphylaxis · Calcific Uremic Arteriolopathy
Primary: Absolute Change in the BWAT - CUA Score for the Primary Lesion — -5.3; -6.0 score on a scale — p=0.877
N/A N=37 Sodium Thiosulfate Treatment of Vascular Calcification in ESRD
Complication of Hemodialysis · Cardiovascular Diseases
Primary: Change in Annualized Coronary Calcium Volume Score After Treatment With Sodium Thiosulfate. — 6.6 mm3/year — p=0.001
N/A N=54 Effect of Citrate Dialysate on Vascular Calcification
Vascular Calcification
Primary: Length of Calcified Artery Segments — 47; 9 millimeters (mm) per year
Phase 4 N=44 Vitamin D and Coronary Calcification Study
Chronic Kidney Disease · Vitamin D Deficiency · Coronary Calcification
Primary: Coronary Artery (CAC) Score Progression — 74.38; 106.32 Agatston units
Phase 2 N=22 The Effect of Etelcalcetide on CKD-MBD
Chronic Kidney Disease Mineral and Bone Disorder · Renal Osteodystrophy · Vascular Calcification
Primary: Percent Change in PTH Levels — 0; -54.14; -64.04 percentage of change in PTH levels
Phase 4 N=360 ADVANCE: Study to Evaluate Cinacalcet Plus Low Dose Vitamin D on Vascular Calcification in Subjects With Chronic Kidney Disease Receiving Hemodialysis
Chronic Kidney Disease · End Stage Renal Disease · Coronary Artery Calcification
Primary: Percent Change From Baseline in CAC Score — 43.74; 57.39 Units on a scale — p=0.073
Phase 2 N=18 A Clinical Trial of Epizon-701 (EPN-701) in Subjects With End-Stage Renal Disease (ESRD)
End-Stage Renal Disease (ESRD)
Primary: Number of Participants With Adverse Events (AEs) — 8 participants
Phase 4 N=309 20070360 Incident Dialysis
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
N/A N=3 Calcium and Phosphorus Whole-Body Balance and Kinetics in Patients With Moderate Chronic Kidney Disease
Phosphorus and Calcium Disorders · Chronic Kidney Disease Mineral and Bone Disorder · Chronic Kidney Diseases
Primary: Fractional Calcium Absorption — 0.30; 0.42 fraction of 1.00
Phase 2 N=110 Bone Biopsy Study For Dialysis Patients With Secondary Hyperparathyroidism of End Stage Renal Disease
Secondary Hyperparathyroidism
Primary: Change From Baseline to End of Study in Bone Formation Rate (BFR) — -488 μm^2/mm^2/day
Phase 4 N=71 A Study of Cinacalcet to Improve Achievement of National Kidney Foundation Kidney Disease Outcomes Quality Initiative (K/DOQI) Targets in Patients With End Stage Renal Disease (ESRD)
Anemia · Secondary Hyperparathyroidism
Primary: Number of Participants With a Mean Intact Parathyroid Hormone Value Between 150 and 300 pg/mL and a Calcium - Phosphorus Product Value < 55 mg^2/dL^2 — 30 Participants
Phase 2 N=274 Effect of SNF472 on Progression of Cardiovascular Calcification in End-Stage-Renal-Disease (ESRD) Patients on Hemodialysis (HD)
Cardiovascular Diseases · Cardiovascular Abnormalities · Calcifications, Vascular
Primary: Change in Log CAC Volume Score From Baseline to Week 52 for the Combined Dose Groups vs Placebo — 1.11; 1.20 ratio
N/A N=141 Renal Osteodystrophy: An Individual Management Approach
Kidney Failure, Chronic
Primary: Change in Quantitative Computed Tomography (QCT) Bone Mineral Density of the Hip — -10.71; 5.72; -3.52; .2 g/cm^3 — p=.443
Phase 4 N=110 Paricalcitol Versus Calcitriol for Efficacy and Safety in Stage 3/4 Chronic Kidney Disease (CKD) With Secondary Hyperparathyroidism (SHPT)
Secondary Hyperparathyroidism · Chronic Kidney Disease
Primary: Confirmed Hypercalcemia — 3; 1 participants — p=0.36
N/A N=12 Calcium and Phosphorus Balance and Calcium Kinetics in Patients With Stage 3/4 Chronic Kidney Disease
Chronic Kidney Disease
Primary: Calcium Balance — 61; 508 mg/d calcium
Phase 4 N=268 Evaluation of the Effectiveness of Paricalcitol Versus Cinacalcet With Low-Dose Vitamin D
Chronic Kidney Disease · Secondary Hyperparathyroidism · Hemodialysis
Primary: The Number of Participants Who Achieve a Mean Intact Parathyroid Hormone (iPTH) Value Between 150 to 300 pg/mL During the Evaluation Period (Weeks 21 to 28). — 30; 16…
Phase 3 N=151 A 4-Week Dose-Ranging and Efficacy Trial of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease
Hyperphosphatemia · End-Stage Renal Disease
Primary: Change in Serum Phosphorus From Baseline to End of Treatment — -0.10; -1.86; -2.13 mg/dL — p=<0.0001
Phase 3 N=35 A Phase III Study of PA21 With Calcium Carbonate in Hemodialysis Patients With Hyperphosphatemia
Hemodialysis · Hyperphosphatemia
Primary: Incidence of Adverse Events — 28 Participants
Phase 2 N=37 Etelcalcetide to Treat Secondary Hyperparathyroidism in Hemodialysis Patients With Chronic Kidney Disease-Mineral and Bone Disorder
Secondary Hyperparathyroidism
Primary: Percent Change From Baseline in Parathyroid Hormone (PTH) During the Efficacy Period — -53.6; -55.6; -50.8 percent change
Phase 4 N=61 Phosphate Lowering in CKD Trial
Chronic Kidney Disease · Cardiovascular Disease
Primary: Brachial Artery Flow-mediated Dilation — 3.13; 3.74; 2.73; 3.09 percent change FMD
Phase 4 N=41 A Study of Zemplar® Injection and Hectorol® Injection on Intestinal Absorption of Calcium in Chronic Kidney Disease
Chronic Kidney Disease, Stage 5 · Secondary Hyperparathyroidism
Primary: Calcium Absorption Fractions Analyzed by Analysis of Variance (ANOVA) — 0.103; 0.108 Fractions — p=0.573
Phase 3 N=30 Sevelamer and Secondary Hyperparathyroidism in Chronic Kidney Disease
Hyperparathyroidism · Chronic Kidney Disease
Primary: Fractional Change in [PTH] in CKD After a 4-week Course of Sevelamer Carbonate — -11.7; 16.4 percentage of baseline [PTH]
Phase 2 N=7 Etidronate for Arterial Calcifications Due to Deficiency in CD73 (ACDC)
Arterial Calcification · CD73 Deficiency
Primary: Ankle-brachial Index at Rest at Pre-treatment, On-treatment and Post-treatment of Etidronate in Participants Diagnosed With ACDC — 0.5741; 0.5411; 0.5222; 0.5266 score…
Phase 1 N=28 Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Hemodialysis Patients With Secondary Hyperparathyroidism
Hyperparathyroidism, Secondary
Primary: Number of Participants With Adverse Events — 2; 1; 1; 1 participants
Phase 3 N=133 Study of the SilverHawk™ /TurboHawk™ Plaque Excision Systems Used With SpiderFX to Treat Calcified Peripheral Arterial Disease (DEFINITIVE Ca++)
Peripheral Arterial Disease
Primary: Successful Revascularization — 92.0 percentage of lesions — p=<0.05
Phase 4 N=65 A Pilot Clinical Study Evaluating the Effect of Parathyroid Hormone (PTH) Lowering On Erythropoietin Consumption in Calcitriol-Resistant Patients
Moderate to Severe Secondary Hyperparathyroidism · Stage 5 Chronic Kidney Diseases
Primary: Mean Erythropoietin Dose Per Visit — 35.8; 22.2; 22.7; 4.7 µg
Phase 3 N=158 Study to Assess the Impact on Calcium Levels When Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT) Switch From Cinacalcet to Etelcalcetide
Hyperparathyroidism, Secondary
Primary: Percentage of Participants With Serum Corrected Calcium < 7.5 mg/dL During the 4-week Treatment Period — 0.7 percentage of participants
Phase 3 N=114 Treatment of Autonomous Hyperparathyroidism in Post Renal Transplant Recipients
Chronic Allograft Nephropathy · Chronic Kidney Disease · Chronic Renal Failure
Primary: Percentage of Participants With a Mean Corrected Total Serum Calcium Value < 10.2 mg/dL (2.55 mmol/L) During the Efficacy Assessment Phase (EAP) — 3.5; 78.9 percentage…
N/A N=21 Calcitonin for Treating X-linked Hypophosphatemia
Hypophosphatemic Rickets, X Linked Dominant
Primary: Area Under the Curve for FGF23 — 3172.34; 3215.34 pg/ml*hr