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
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=10 Role of Extrarenal 1-Alpha-Hydroxylase in Patients With End Stage Renal Disease
End-Stage Renal Disease
Primary: Change in Monocyte VDR Expression With Vitamin D Therapy — 1899 units on a scale
Phase 2 N=61 Bone Mass and Strength After Kidney Transplantation
End Stage Renal Disease · Kidney Transplantation · Bone Loss
Primary: Percent Change in Bone Density From Pre to Post-calcitriol Treatment Compared to Placebo as Assessed by Both Standard Methodologies — -0.81; -0.70 percent change
Phase 3 N=90 Denosumab for Prevention of Osteoporosis in Renal Transplant Recipients
Osteoporosis · Chronic Kidney Disease
Primary: Percent Change in BMD at the Total Lumbar Spine From Baseline to Month 12 — 4.5; -0.3 percent change — p=<0.001
Phase 2 N=42 Randomized Trial of Risedronate to Prevent Bone Loss in Renal Transplant Recipients.
Renal Transplant Osteodystrophy
Primary: Bone Mineral Density of Spine at 6 Months — 0.98; 0.97 gm/cm^2
Phase 2 N=54 Study for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients
Secondary Hyperparathyroidism · Chronic Renal Insufficiency
Primary: Reduction in Mean iPTH of ≥ 30% During the Efficacy Assessment Phase — 15; 5 Participants — p=0.006
Phase 4 N=204 Efficacy of Vitamin D2 to Treat Chronic Kidney Disease Mineral and Bone Disorder
Vitamin D Deficiency
Primary: The Blood Levels of Calcium at the 24th Month of Following up. — 2.31; 2.33 mmol/L — p=0.117
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
N/A N=90 Vitamin D Replacement After Kidney Transplant
Kidney Transplantation · Vitamin D Deficiency
Primary: Compare Efficacy and Safety of Two Vitamin D Supplements of These Doses in Normalizing Vitamin D Concentrations. — 8; 29 ng/ml
Phase 2 N=30 Role Of Phosphorus And FGF 23 In Patients With Dent Disease
Dent Disease
Primary: Change in Urine Total Protein — 1681; 59 mg/day
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 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 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…
N/A N=47 Cholecalciferol Versus Doxercalciferol in the Treatment of Secondary Hyperparathyroidism in Chronic Kidney Disease
Renal Osteodystrophy
Primary: Percent Reduction in PTH — 27; 10 % change in PTH baseline to 3 months
Phase 4 N=92 Trial to Optimize Mineral Outcomes in Dialysis Patients
Secondary Hyperparathyroidism · Chronic Kidney Disease
Primary: Percent of Patients Achieving Parathyroid Hormone Target ≤ 300 — 21 percentage of subjects meeting target — p=< 0.05
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=29 Calcium Absorption in Patients With Rothmund-Thomson Syndrome
Rothmund-Thomson Syndrome
Primary: Bone Density (Low Areal Bone Mineral Density (aBMD)) — -1.3; -0.9; -2.4; -1.2 z-score
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 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 1 N=32 Multiple Dose Study to Evaluate the Safety of Multiple Doses of Denosumab 120 mg in Adults With Severe Chronic Kidney Disease (CKD) and CKD on Dialysis
Renal Impairment
Primary: Number of Participants With Clinically Significant Hypocalcemia — 1; 2 participants
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 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=56 Impact of Vitamin D Therapies on Chronic Kidney Disease
Chronic Kidney Disease (CKD) · End-stage Renal Disease (ESRD)
Primary: Monocyte Protein Expression — 34110; 38540; 1359; 1360 relative fluorescence units
Phase 3 N=202 Evaluation of Renvela in Patients With Chronic Kidney Disease Not On Dialysis And Hyperphosphatemia In China
Hyperphosphatemia
Primary: Change From Baseline in Serum Phosphorus at Week 8 — 2.090; 2.095; 0.010; -0.200 mmol/L — p=<0.0001
N/A N=43 Fibroblast Growth Factor-23 (FGF23) Reduction in Predialysis Chronic Kidney Disease (CKD)
Kidney Disease
Primary: Percentage Changes in Fibroblast Growth Factor-23 (FGF-23) Levels — -0.35; 0.25; 0.00; -0.02 percentage of change from baseline
Phase 3 N=216 Evaluate Safety and Efficacy of Paricalcitol in Reducing Serum Intact Parathyroid Hormone in Chronic Kidney Disease
Chronic Kidney Disease
Primary: The Achievement of Two Consecutive Greater Than or Equal to 30% Decreases From Baseline Intact Parathyroid Hormone Levels — 93; 57; 12; 45 participants
Phase 2 N=55 Supplementation With Cholecalciferol in Dialysis Patients
Chronic Kidney Disease
Primary: Change From Baseline in Interleukin-6 at 12 Weeks. — 9.0; 8.1; 9.6; 4.6 pg/mL
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
N/A N=20 Vitamin D Supplementation in Kidney Disease
Renal Dialysis · Vitamin D Deficiency
Primary: Change in Hip Flexor Strength — 20.34; 6.83 percent change
Phase 4 N=120 Paricalcitol Versus Calcitriol for the Management of Renocardiac Syndrome in Renal Transplant Patients
Cardiorenal Syndrome · Chronic Allograft Nephropathy
Primary: CAD (Chronic Allograft Dysfunction) Degree — 1.24; 1.22; 1.43; 1.68 Scores on a Banff scale — p=<0.05