Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet
Secondary HyperparathyroidismChronic Kidney DiseaseThe purpose of this study is to demonstrate that treatment with etelcalcetide (AMG 416) is not inferior to treatment with cinacalcet for lowering serum parathyroid hormone (PTH) levels by > 30% from baseline among patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT) who require management with hemodialysis.
A Phase 2 Study of an Oral Vitamin D Compound (DP001) in Secondary Hyperparathyroidism in Patients...
HyperparathyroidismSecondary2 moreThe goal of this study is to test a new vitamin D compound for its ability to reduce parathyroid hormone levels in patients who are on hemodialysis.
A Randomized Study of Surgery vs No Surgery in Patients With Mild Asymptomatic Primary Hyperparathyroidism...
HyperparathyroidismOBJECTIVES: I. Assess the efficacy of surgery vs no surgery in patients with mild asymptomatic primary hyperparathyroidism. II. Assess the quality of life, morbidity, and mortality of these patients.
Evaluation of the Effectiveness of Paricalcitol Versus Cinacalcet With Low-Dose Vitamin D
Chronic Kidney DiseaseSecondary Hyperparathyroidism1 moreEvaluates the effectiveness of on-label Paricalcitol versus Cinacalcet with Low-Dose Vitamin D.
Paricalcitol Compared to Maxacalcitol in Chronic Kidney Disease Patients With Secondary Hyperparathyroidism...
Secondary HyperparathyroidismHemodialysisThis study is a exploratory comparison of the efficacy and safety of paricalcitol injection with maxacalcitol injection in chronic kidney disease participants receiving hemodialysis with secondary hyperparathyroidism.
Treatment of Autonomous Hyperparathyroidism in Post Renal Transplant Recipients
Chronic Allograft NephropathyChronic Kidney Disease8 moreHyperparathyroidism (HPT) is common in people with a kidney transplant. Patients with HPT often have high parathyroid hormone (PTH) levels and may have large parathyroid glands in the neck. Patients with HPT can develop bone disease (osteodystrophy). This bone disease can cause bone pain, fractures, and poor formation of red blood cells. Other problems from HPT may include increases in blood levels of calcium (hypercalcemia) and low blood levels of phosphorus (hypophosphatemia). The high calcium levels may cause calcium to deposit in body tissues. Calcium deposits can cause arthritis (joint pain and swelling), muscle inflammation, itching, gangrene (death of soft tissue), heart and lung problems or kidney transplant dysfunction (worsening of kidney transplant function). The purpose of this study is to evaluate the effects of cinacalcet (Sensipar/Mimpara) on high calcium levels in the blood in patients with HPT after a kidney transplant.
Pharmacokinetics and Safety Pilot Study of Single-Dose Oral and Intravenous CTAP101 in Stage 3 and...
Chronic Kidney DiseaseSecondary Hyperparathyroidism2 moreThis study will investigate how the levels of a single dose of CTAP101 changes in the body over time (pharmacokinetics, PK) and how CTAP101 affects other mineral and hormonal balances (pharmacodynamics, PD) in patients with Stage 3 or 4 chronic kidney disease (CKD) with vitamin D insufficiency and secondary hyperparathyroidism (SHPT).
How Vitamin D Analogues Affect Endothelial Cells in Patients on Dialysis
HyperparathyroidismSecondary2 morePatients with chronic kidney disease and end stage renal disease have greater cardiovascular risk than the general population. Vitamin D analogues have been shown in observational studies to have mortality benefit for these patients. This study is designed to investigate doxercalciferol's effect on the vasculature (i.e. endothelial cell function) as a possible mechanism to explain the mortality benefit.
A Phase 4, Conversion Study of Hectorol® Injection to Hectorol® Capsules in Stage 5 CKD Patients...
Secondary HyperparathyroidismHectorol is a safe and effective treatment of secondary hyperparathyroidism in hemodialysis patients. Hectorol (doxercalciferol capsules) is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis and in pre-dialysis patients with Stage 3 or Stage 4 chronic kidney disease. Hectorol (doxercalciferol injection) is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis. This protocol will determine clinically appropriate doses of Hectorol (doxercalciferol capsules) when converting subject from Hectorol (doxercalciferol injection.) The study will enroll hemodialysis patients that have been controlled on intravenous Hectorol. the information gained from this study will be a useful guide for physicians in managing CKD Stage 5 patients for whom a change from intravenous to oral vitamin D administration is appropriate.
Evaluation of Colecalciferol Substitution in Dialysis Patients
RENAL INSUFFICIENCYCHRONIC2 moreThe purpose of this study is to determine the effect of a colecalciferol substitution in dialysis patients on bone metabolism and immune system