Clinical trials: Chronic Malnutrition
Chronic Kidney Disease, Hyperparathyroidism, Secondary
Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency
This study will evaluate the efficacy of CTAP101 Capsules versus placebo in reducing intact parathyroid hormone (iPTH) by at least 30% from pretreatment baseline; safety and tolerability of CTAP101 will also be evaluated
- Conditions
- Chronic Kidney Disease, Hyperparathyroidism, Secondary, Vitamin D Deficiency
- Trial name
- NCT01704079
- Testing
- CTAP101 30 μg capsules, Sugar pill to CTAP101 30 μg capsules
- Where
- United States
- Volunteers
- 216 people
- Sponsor
- OPKO IP Holdings II, Inc.
Chronic Kidney Disease stage3, Chronic Kidney Disease stage4
Phase 3 Safety and Efficacy Study of CTAP101 Extended-release Capsules in Children With Secondary Hyperparathyroidism
This is a phase 3, multi-center, randomized, double-blind, placebo-controlled study in children with stage 3-4 chronic kidney disease (CKD), secondary hyperparathyroidism (SHPT) and vitamin D insufficiency.
- Conditions
- Chronic Kidney Disease stage3, Chronic Kidney Disease stage4, Vitamin d Deficiency, Secondary Hyperparathyroidism
- Trial name
- NCT05543928
- Testing
- CTAP101
- Where
- 2 sites in United States
- Volunteers
- 2 people
- Sponsor
- OPKO Health, Inc.
Malnutrition
COPD: Oral Nutrition Supplements vs. Energy- and Protein Dense in Between Meal Snacks.
At least one fifth of patients in European hospitals are malnourished. Malnutrition is associated with negative consequences, including higher rates of complications, longer hospital stay, impaired wound healing and increased…
- Trial name
- COPD (NCT02251496)
- Testing
- In between meals snacks (Snacks-group), Oral nutrition supplement (ONS-group)
- Where
- Iceland
- Volunteers
- 34 people
- Sponsor
- University of Iceland
Secondary Hyperparathyroidism
Open-label Study to Assess the Long-term Safety and Efficacy of Etelcalcetide (Also Known as AMG 416 or KAI-4169) in Patients With Secondary Hyperparathyroidism
The purpose of this study is to evaluate the long term safety and efficacy of thrice weekly intravenous (IV) administration of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in patients receiving…
- Trial name
- NCT01576146
- Testing
- Etelcalcetide
- Volunteers
- 30 people
- Sponsor
- KAI Pharmaceuticals
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
Osteoporosis, Renal Osteodystrophy
The Effects of 12-months of Denosumab on Bone Density in Prevalent Kidney Transplant Recipients
This is a Phase 2 Multi-Center Clinical Trial (safety and effectiveness trial) in 60 patients (40 denosumab; 20 placebo) who have had a kidney transplant for 12-months or longer with more than 30% of kidney function.
- Conditions
- Osteoporosis, Renal Osteodystrophy, Kidney Transplant; Complications
- Trial name
- ProliaKTx (NCT03960554)
- Testing
- Denosumab Inj 60 mg/ml
- Where
- 3 sites in United States
- Volunteers
- 8 people
- Sponsor
- Thomas Nickolas, MD MS
Vitamin D Deficiency, End-stage Renal Disease
Impact of Vitamin D Repletion in Hemodialysis Patients
Dialysis patients often suffer from defects in their immune system (that part of the body which fights infection). Evidence suggests that Vitamin D deficiency may have a negative effect on immunity, and many dialysis patients are…
- Trial name
- NCT01175798
- Testing
- Cholecalciferol
- Where
- United States
- Volunteers
- 116 people
- Sponsor
- Mehrotra, Anita, M.D.
Pancreatitis, Chronic
Prospective Study of Efficacy of Intra-muscular Vitamin D3 in Tropical Calcific Pancreatitis
The purpose of this study is to determine the efficacy of 2 different doses of intramuscular (IM) vitamin D3 as compared to an oral replacement dose in normalizing vitamin D levels in the blood of patients with tropical calcific…
- Trial name
- NCT00956839
- Testing
- Vitamin D3 (Cholecalciferol)
- Where
- India
- Volunteers
- 40 people
- Sponsor
- Sanjay Gandhi Postgraduate Institute of Medical Sciences
Cardiovascular Disease, Chronic Kidney Disease
Vascular Risk After Kidney Transplantation
Hypothesis: Nontraditional risk factors, such as inflammation, vitamin D deficiency, elevated PTH, insulin resistance, homocysteine, or uric acid, contribute to cardiovascular disease progression after kidney transplant.
- Conditions
- Cardiovascular Disease, Chronic Kidney Disease, Diabetes, Vitamin D Deficiency
- Trial name
- NCT00374595
- Where
- United States
- Volunteers
- 338 people
- Sponsor
- University of Nebraska
Chronic Kidney Disease, Hyperparathyroidism, Secondary
Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency
This study will evaluate the efficacy of CTAP101 Capsules versus placebo in reducing intact parathyroid hormone (iPTH) by at least 30% from pretreatment baseline; safety and tolerability of CTAP101 will also be evaluated
- Conditions
- Chronic Kidney Disease, Hyperparathyroidism, Secondary, Vitamin D Deficiency
- Trial name
- NCT01651000
- Testing
- CTAP101 30 μg capsules, Sugar pill to CTAP101 30 μg capsules
- Where
- United States
- Volunteers
- 213 people
- Sponsor
- OPKO IP Holdings II, Inc.
Chronic Lymphocytic Leukemia, Non-Hodgkin Lymphoma
Cholecalciferol in Newly Diagnosed Non-Hodgkin Lymphoma or Chronic Lymphocytic Leukemia With Vitamin D Deficiency
This randomized pilot early phase I trial studies how well cholecalciferol works in treating patients with newly diagnosed non-Hodgkin lymphoma or chronic lymphocytic leukemia with low levels of vitamin D (vitamin D deficiency).
- Conditions
- Chronic Lymphocytic Leukemia, Non-Hodgkin Lymphoma, Untreated Chronic Lymphocytic Leukemia, Vitamin D Deficiency
- Trial name
- NCT02553447
- Testing
- Cholecalciferol, Laboratory Biomarker Analysis
- Where
- United States
- Volunteers
- 197 people
- Sponsor
- University of Nebraska
Chronic Kidney Disease Mineral and Bone Disorder, Renal Osteodystrophy
The Effect of Etelcalcetide on CKD-MBD
The proposed study will investigate the effects of etelcalcetide on the bone and blood-vessel health in patients with CKD-MBD. The investigators will test if etelcalcetide makes bone and blood-vessels healthier.
- Conditions
- Chronic Kidney Disease Mineral and Bone Disorder, Renal Osteodystrophy, Vascular Calcification, Hyperparathyroidism; Secondary, Renal
- Trial name
- Parsabiv-MBD (NCT03960437)
- Testing
- Etelcalcetide
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Thomas Nickolas, MD MS
Secondary Hyperparathyroidism
Etelcalcetide to Treat Secondary Hyperparathyroidism in Hemodialysis Patients With Chronic Kidney Disease-Mineral and Bone Disorder
The purpose of this study is to evaluate the effect of thrice weekly intravenous (IV) administration of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in hemodialysis patients with chronic kidney…
- Trial name
- NCT01414114
- Testing
- Etelcalcetide
- Volunteers
- 37 people
- Sponsor
- KAI Pharmaceuticals
Renal Osteodystrophy
Cholecalciferol Versus Doxercalciferol in the Treatment of Secondary Hyperparathyroidism in Chronic Kidney Disease
The majority of patients with moderate to severe chronic kidney disease (CKD) (stages 3 and 4) develop secondary hyperparathyroidism (2°HPT), but the optimal therapy to control hyperparathyroidism in this group is unknown.
- Trial name
- NCT00285467
- Testing
- doxercalciferol, Cholecalciferol
- Where
- United States
- Volunteers
- 55 people
- Sponsor
- Indiana University
Chronic Kidney Disease, Hyperparathyroidism, Secondary
Extension Study of CTAP101-CL-3001 or CTAP101-CL-3002
This extension study of subjects previously enrolled in studies CTAP101-CL-3001 or CTAP101-CL-3002 allows long term evaluation of the safety and efficacy of CTAP101 Capsules in reducing elevated intact parathyroid hormone (iPTH)…
- Conditions
- Chronic Kidney Disease, Hyperparathyroidism, Secondary, Vitamin D Deficiency
- Trial name
- NCT02282813
- Testing
- CTAP101 Capsules, Calcitriol, Doxercalciferol
- Volunteers
- 298 people
- Sponsor
- OPKO Health, Inc.
Vitamin D Deficiency
Efficacy of Vitamin D2 to Treat Chronic Kidney Disease Mineral and Bone Disorder
It is hypothesised that the efficacy and safety of Vitamin D2 soft capsule to treat the Chronic Kidney Disease Mineral and Bone Disease (CKD-MBD) are equal to 1,25(OH)2 Vitamin D3 (Rocaltrol) in the patients with CKD stage 3-5.
- Trial name
- NCT01633853
- Testing
- Vitamin D2, 1,25(OH)2 Vit D3
- Where
- China
- Volunteers
- 204 people
- Sponsor
- Dongliang Zhang, MD
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.
End Stage Renal Disease, Olfactory Disorders
Helping Olfaction and Nutrition On Renal Replacement
This clinical trial examines whether nasal theophylline administration can improve olfaction and nutrition in hemodialysis patients.
- Trial name
- HONORR (NCT02479451)
- Testing
- Theophylline
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Massachusetts General Hospital
End Stage Renal Disease
Safety and Efficacy Study of the Effect of Etanercept in Hemodialysis Patients
Etanercept is a novel anti-inflammatory agent currently used in patients with rheumatoid arthritis. We are examining whether Etanercept is effective in improving the nutritional status of hemodialysis patients as a consequence of…
- Trial name
- NCT00293202
- Testing
- Etanercept
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Kaysen, George A., M.D., Ph.D.
Coronary Artery Disease, Chronic Kidney Disease
Effect of Vitamin D Supplement on Inflammation Markers in High-Risk Cardiovascular Patients With Chronic Kidney Disease
The purpose of this study is to determine if vitamin D supplementation changes the results of certain tests associated with inflammation in the body using an oral, synthetic form of vitamin D called paricalcitol.
- Conditions
- Coronary Artery Disease, Chronic Kidney Disease, Hypovitaminosis D, Secondary Hyperparathyroidism
- Trial name
- VINCA-CKD (NCT01012414)
- Testing
- paricalcitol
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Thomas Jefferson University