Clinical trials: Hyperparathyroidism; Secondary, Renal
Secondary Hyperparathyroidism Due to Renal Causes, Vitamin D Insufficiency
Repeated-dose Safety, Efficacy, Pharmacokinetic and Pharmacodynamic of CTAP101, Immediate-release Calcifediol, High-dose Cholecalciferol, and Paricalcitol Plus Low-dose Cholecalciferol in Patients With Secondary Hyperparathyroidism, Chronic Kidney Disease 3-4 and Vitamin D Insufficiency
An Open-Label, Repeated-Dose Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Study of Oral CTAP101 Capsules, Immediate- Release (IR) Calcifediol, High-Dose Cholecalciferol, and Paricalcitol Plus Low-Dose Cholecalciferol in…
- Conditions
- Secondary Hyperparathyroidism Due to Renal Causes, Vitamin D Insufficiency, CKD Stage 3, CKD Stage 4
- Trial name
- NCT03588884
- Testing
- Calcifediol Oral Capsule, Calcifediol Oral Product, Cholecalciferol
- Where
- 3 sites in United States
- Volunteers
- 69 people
- Sponsor
- OPKO Health, Inc.
Kidney Diseases, Dialysis; Complications
PRevEnting FracturEs in REnal Disease - 1
PREFERRED-1 is a pilot study designed to determine the feasibility of a large randomized, pragmatic, open-label, comparative-effectiveness trial of denosumab for the prevention of fragility fractures in people receiving…
- Conditions
- Kidney Diseases, Dialysis; Complications, Fragility Fracture, Chronic Kidney Disease-Mineral and Bone Disorder
- Trial name
- PREFERRED-1 (NCT05096195)
- Testing
- Denosumab 60 mg/ml, Calcium and vitamin D prophylaxis, Monitoring of post-injection calcium and phosphate
- Where
- 6 sites in Canada
- Volunteers
- 60 people
- Sponsor
- Western University, Canada
Chronic Kidney Diseases, Hyperphosphatemia
Improving Phosphate Control in Children With CKD
Research goals: To explore the views and baseline knowledge of children and young people (CYP) with CKD and their caregivers to develop effective phosphate educational materials (PEM), adapted for age, and acknowledging different…
- Conditions
- Chronic Kidney Diseases, Hyperphosphatemia, Pediatric Kidney Disease, CKD-MBD
- Trial name
- IMPACT (NCT05439980)
- Testing
- Knowledge questionnaire, Focus groups
- Where
- United Kingdom
- Volunteers
- 100 people
- Sponsor
- Great Ormond Street Hospital for Children NHS Foundation Trust
Renal Osteodystrophy
Systematic Study of Parameters of Chronic Kidney Disease Mineral and Bone Disorder (CKD-MBD)
Bone and mineral disease is a key problem in patients with kidney disease. The available clinical parameters are non-specific, unproven for the assessment of the bone metabolism and do not reflect the complexity and diversity of…
- Trial name
- BoneX (NCT02556216)
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- Hannover Medical School
Chronic Kidney Disease, Secondary Hyperparathyroidism
Active Vitamin D Effect on Left Ventricular Hypertrophy
Left ventricular hypertrophy (LVH) predicts mortality at start of dialysis. Prevention of of LVH is important. It is not known whether secondary hyperparathyroidism might induce LVH.
- Conditions
- Chronic Kidney Disease, Secondary Hyperparathyroidism, Left Ventricular Hypertrophy
- Trial name
- NCT00175149
- Testing
- Alfacalcidiol
- Where
- Denmark
- Volunteers
- 24 people
- Sponsor
- Per Ivarsen
Chronic Kidney Disease Mineral and Bone Disorder
Phosphorus Absorption in Healthy Adults and in Patients With Moderate Chronic Kidney Disease
Chronic kidney disease (CKD) affects approximately 26 million Americans with many more at risk for disease development. Elevated serum phosphorus (P) and related abnormalities in P homeostasis due to progressive loss of kidney…
- Trial name
- NCT03108222
- Testing
- Phosphorus Absorption Test
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Purdue University
Kidney Tansplant, Secondary Hyperparathyroidism
Post Transplant Study
Retrospective chart review to gather information on Sensipar patterns of use and effects on biochemical parameters in renal transplant recipients
- Conditions
- Kidney Tansplant, Secondary Hyperparathyroidism, Hyperparathyroidism
- Trial name
- NCT00395902
- Testing
- Sensipar after Post Transplant
- Volunteers
- 50 people
- Sponsor
- Amgen
Chronic Kidney Disease Mineral and Bone Disorder, Chronic Kidney Disease (CKD)
The CPH-MBD Cohort
Persons with chronic kidney disease (CKD) have a 3-fold increased risk of bone fracture and a 10-fold increased risk of cardiovascular disease than the general population.
- Conditions
- Chronic Kidney Disease Mineral and Bone Disorder, Chronic Kidney Disease (CKD), Bone Markers
- Trial name
- NCT07193056
- Where
- Denmark
- Volunteers
- 1,000 people
- Sponsor
- Herlev Hospital
Secondary Hyperparathyroidism Due to Renal Causes, Chronic Kidney Diseases
Safety, Efficacy, PK and PD of CTAP101 (Calcifediol) ER Capsules for SHPT in HD Patients VDI
Safety, Efficacy, PK and PD of CTAP101 (calcifediol) ER Capsules for SHPT in HD Patients VDI
- Conditions
- Secondary Hyperparathyroidism Due to Renal Causes, Chronic Kidney Diseases, Vitamin D Deficiency, Stage 5 Chronic Kidney Disease
- Trial name
- NCT03602261
- Testing
- Calcifediol Oral Capsule
- Where
- 18 sites in United States
- Volunteers
- 44 people
- Sponsor
- OPKO Health, Inc.
Secondary Hyperparathyroidism
Safety, Tolerability and Efficacy of Etelcalcetide in Hemodialysis Patients With Secondary Hyperparathyroidism
The purpose of this study is to characterize the safety and tolerability and efficacy of multiple ascending doses of etelcalcetide in hemodialysis patients for the treatment of secondary hyperparathyroidism (HPT).
- Trial name
- NCT01254565
- Testing
- Etelcalcetide
- Where
- 13 sites in United States
- Volunteers
- 87 people
- Sponsor
- KAI Pharmaceuticals
Stage 5 Chronic Kidney Disease (CKD), Secondary Hyperparathyroidism (SHPT)
Four Week, Pharmacodynamic/Pharmacokinetic, Efficacy, and Safety Study of Lunacalcipol (CTA018)
Open-label, pharmacodynamic, safety, pharmacokinetic and efficacy study of Lunacalcipol Injection.
- Conditions
- Stage 5 Chronic Kidney Disease (CKD), Secondary Hyperparathyroidism (SHPT), Hemodialysis (HD)
- Trial name
- 2007 (NCT01453634)
- Testing
- Lunacalcipol 180, Lunicalcipol 270
- Sponsor
- OPKO Health, Inc.
Secondary Hyperparathyroidism
A Phase 4 Study to Determine Dosing of Hectorol® Capsules When Converting From Zemplar® Injection
Protocol HECT00306 aims to determine clinically appropriate doses of Hectorol (doxercalciferol capsules) when converting from Zemplar (paricalcitol injection) for the treatment of secondary hyperparathyroidism in Stage 5 chronic…
- Trial name
- NCT00463021
- Testing
- Hectorol (doxercalciferol capsules), Zemplar (paricalcitol injection)
- Where
- 8 sites in United States
- Volunteers
- 36 people
- Sponsor
- Genzyme, a Sanofi Company
Phosphorus and Calcium Disorders, Chronic Kidney Disease Mineral and Bone Disorder
Calcium and Phosphorus Whole-Body Balance and Kinetics in Patients With Moderate Chronic Kidney Disease
This pilot study aims to develop a method for simultaneous whole-body calcium and phosphorus balance and full kinetic modeling of both ions in patients with chronic kidney disease.
- Conditions
- Phosphorus and Calcium Disorders, Chronic Kidney Disease Mineral and Bone Disorder, Chronic Kidney Diseases
- Trial name
- NCT04019379
- Testing
- High Phosphorus Diet, Low Phosphorus Diet
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- University of Minnesota
Hyperparathyroidism; Secondary, Renal
Efficacy and Safety of Cinacalcet in Ca, P and iPTH Levels in Patients With Mild, Moderate and Severe SHPT
1. To evaluate achievement ratio of iPTH,Calcium and phosphorus after taking Cinacalcet HCL in hemodialysis subjects with mild, moderate and severe SHPT; 2.
- Trial name
- ACTIVE (NCT03123406)
- Testing
- Cinacalcet HCl
- Where
- China
- Volunteers
- 750 people
- Sponsor
- Kyowa Kirin China Pharmaceutical Co., Ltd.
Secondary Hyperparathyroidism
Parathyroidectomy vs Cinacalcet in the Treatment of Secondary Hyperparathyroidism Post Renal Transplantation
The hypothesis of this study is that subtotal parathyroidectomy using minimally invasive surgery is superior to cinacalcet for the treatment of persistent secondary hyperparathyroidism (HPT) post renal transplant, with minimal…
- Trial name
- NCT01178450
- Testing
- Subtotal parathyroidectomy, Cinacalcet
- Where
- 2 sites in Spain
- Volunteers
- 30 people
- Sponsor
- Josep M Cruzado
Renal Transplant, Secondary Hyperparathyroidism
Paricalcitol in Reducing Parathyroid Hormone Levels and Ameliorating Markers of Bone Remodelling in Renal Transplant Recipients With Secondary Hyperparathyroidism
The risk of fracture for kidney transplant recipients is 4 times higher that of the general population. The hyperparathyroidism plays a key role in the maintenance or development of post-transplant alterations of bone…
- Trial name
- APPLE (NCT01220050)
- Testing
- Paricalcitol, Standard therapy
- Where
- Italy
- Volunteers
- 43 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Secondary Hyperparathyroidism, Renal Insufficiency, Chronic
Effectiveness and Safety of IV Zemplar in Patients on Hemodialysis and With Secondary Hyperparathyroidism Using iPTH/100 as Initial Dose
The purpose of this study is to observe the effectiveness and safety of the use of a low initial dose regime (iPTH/100) in chronic kidney disease patients with secondary hyperparathyroidism (PTH>300pg/mL) and that require…
- Conditions
- Secondary Hyperparathyroidism, Renal Insufficiency, Chronic, Parathyroid Hormone, Hemodialysis
- Trial name
- NCT00891813
- Testing
- Zemplar (paricalcitol)
- Where
- 3 sites in Peru
- Volunteers
- 100 people
- Sponsor
- Abbott
Chronic Kidney Disease Mineral and Bone Disorder, Hypertension
Reducing Inflammation to Improve Vascular and Bone Outcomes With Low-dose Colchicine in CKD
The overall objective of this pilot randomized clinical trial is to determine whether low-dose Colchicine (LoDoCo) improves vascular disease including vascular calcification, peripheral arterial disease (PAD), and chronic kidney…
- Conditions
- Chronic Kidney Disease Mineral and Bone Disorder, Hypertension, Diabetes, Dyslipidemia
- Trial name
- RESOLVE-CKD (NCT07654231)
- Testing
- Low-dose Colchicine at 0.5mg daily, Usual Care
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- University of Texas Southwestern Medical Center
Chronic Kidney Disease (Stage 3-4), Chronic Kidney Disease Mineral and Bone Disorder
Phosphate Assessment in Chronic Kidney Disease Patients Study
The proposed pilot feeding study aims to explore novel pathways in phosphate metabolism and identify new biomarkers, as well as to develop a compound index for assessing phosphate overload with high validity and reliability.
- Trial name
- PACK (NCT07368946)
- Testing
- Dietary Phosphorus Intake
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- University of Texas Southwestern Medical Center
Secondary Hyperparathyroidism, Hypercalcemia
Cinacalcet to Treat Hypercalcemia in Renal Transplant Recipients
Secondary hyperparathyroidism can persist following successful renal transplantation and can cause high blood calcium, kidney dysfunction or failure and excessive bone loss among other problems.
- Trial name
- NCT00415584
- Testing
- Cinacalcet HCl
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Montefiore Medical Center