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.
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 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=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
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 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=100 Oral Paricalcitol in Kidney Transplant Recipients
Transplant; Failure, Kidney · Renal Disease, End Stage · Hyperparathyroidism, Secondary
Primary: Number of Subjects With Hyperparathyroidism at One Year — 31; 15 Participants — p=0.0005
N/A N=59 Effects of Zoledronic Acid Versus Alendronate on Bone Loss After Kidney and Kidney/Pancreas Transplants
Renal Insufficiency
Primary: Percentage Change in Posterior Anterior (PA) Spine Bone Density From Baseline to 24 Months Post Transplant — 8.1; 6.6; 6.5 percentage of change of bone density
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
Phase 4 N=94 Efficacy and Safety of Paricalcitol in the Reduction of Secondary Hyperparathyroidism After Kidney Transplantation.
Secondary Hyperparathyroidism Due to Renal Causes
Primary: Percentage of Patients With iPTH Serum Concentration >110 pg/mL. — 9; 16; 32; 27 Participants — p=0.0083
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
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
N/A N=338 Vascular Risk After Kidney Transplantation
Cardiovascular Disease · Chronic Kidney Disease · Diabetes
Primary: Carotid Intima Media Thickness (CIMT) — 0.044 millimeters (mm)
Phase 2 N=30 Denosumab in Treating Patients With Bone Loss Due to Donor Stem Cell Transplant
Allogeneic Hematopoietic Stem Cell Transplantation Recipient · Osteopenia · Osteoporosis
Primary: Mean Total Hip Percent Change in Bone Mineral Density (BMD) — -4.28 percent change
Phase 3 N=78 Prevention of Osteoporosis in Bone Marrow Transplantation (BMT) Patients
Hematological Malignancies
Primary: Percentage Change in Bone Mineral Density From Baseline to 6 and 12 Months — 0.06; -2.61; -3.63; -4.85 Percentage change
Phase 2 N=61 Zoledronic Acid in Preventing Osteoporosis in Patients Undergoing Donor Stem Cell Transplant
Leukemia · Lymphoma · Myelodysplastic Syndromes
Primary: Mean Change in Bone Mineral Density — -0.0714; -0.0036 percent
Phase 3 N=194 Progression of Renal Interstitial Fibrosis / Tubular Atrophy (IF/TA) According to Epithelial-mesenchymal Transition (EMT) and Immunosuppressive Regimen (Everolimus Based Versus CNI Based) in de Novo Renal Transplant Recipients
Renal Interstitial Fibrosis
Primary: Number of Participants With Progression of Renal Graft Fibrosis (Primary Comparison - ITT Population — 26; 31; 12; 16 Participants
Phase 3 N=88 Erythropoietin (EPO) and Ischemia-reperfusion After Kidney Transplantation
Kidney Transplantation
Primary: Kidney Graft Function by Estimated Glomerular Filtration Rate (eGFR) — 47; 46 ml/min — p=<0.05
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
N/A N=2 Combined Bone Marrow and Renal Transplantation for Hematologic Disorders With End Stage Renal Disease
Multiple Myeloma · Amyloidosis
Primary: Number of Participants Without Renal Allograft Rejection at 6 Months Post-transplant — 1 Participants
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 3 N=111 Zoledronic Acid Versus Alendronate for Prevention of Bone Loss After Organ Transplantation
Heart Transplantation · Liver Transplantation · Bone Resorption
Primary: Percentage Change From Baseline in Total Hip Bone Mineral Density (BMD) at 12 Months — 0.39; -0.21; -2.2 percent change
Phase 2 N=63 Prevention of Bone Loss After Pediatric Hematopoietic Cell Transplantation
Osteopenia · Osteoporosis
Primary: Lumbar Spine Bone Mineral Content — 41.4; 38.7 Average grams
N/A N=60 Hyperglycemia in Renal Transplantation
Diabetes · End Stage Renal Disease
Primary: Incidence of Poor Graft Function After Kidney Transplant — 13; 22 Participants
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=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=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=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=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=81 Lipid Management in Renal Transplant Recipients Using Evolocumab.
Hyperlipidemias
Primary: Percent Change in LDL Cholesterol From Baseline to 12 Months — -46.6 Percent (%)