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.
End Stage Renal Disease (ESRD)
Evaluate the Efficacy and Safety of Amino Acid (15) Peritoneal Dialysis Solution in Peritoneal Dialysis Patients with Malnutrition.
This is a multicenter, randomized, parallel controlled Phase IV clinical study to evaluate the safety and efficacy of amino acid (15) peritoneal dialysis solution in patients undergoing peritoneal dialysis with malnutrition in…
- Trial name
- NCT06597201
- Testing
- amino acid (15) peritoneal dialysis solution, glucose peritoneal dialysis solution
- Where
- 21 sites in China
- Volunteers
- 400 people
- Sponsor
- Chengdu Qingshan Likang Pharmaceutical Co., Ltd
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 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.
Fecal Microbiota Transplantation
Metabonomics of COPD and Transplanting of Faecal Bacteria in the Treatment of Its Malnutrition
Oxidative stress can affect the balance of intestinal flora and intestinal structure of patients, resulting in intestinal flora disorder.
- Trial name
- NCT04861649
- Testing
- fecal microbiota transplantation
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Shanghai Asclepius Meditec Inc.
End Stage Renal Disease
A Phase II, Randomized, Cross-Over, Vehicle-Controlled, Double-Blind, Multicenter Study of the Safety, Pharmacodynamics, and Preliminary Efficacy of GHRP-1/AG in Subjects With ESRD on Hemodialysis
Malnutrition and altered protein catabolism are serious problems in renal failure and hemodialysis (HD) patients. The purpose of this study is to characterize the safety of GHRP-1/AG in subjects with ESRD on HD; to characterize…
- Trial name
- NCT00381602
- Testing
- GHRP-1/AG 70 mg depot in ESRD
- Where
- 2 sites in United States
- Volunteers
- 3 people
- Sponsor
- QLT Inc.
Chronic Kidney Disease, Renal Failure Chronic Requiring Hemodialysis
Specific Enteral Nutrition in Malnourished, Dialysis Patients With Chronic Kidney Disease. Efficacy, Safety, Quality of Life
The objective of this unblinded study is to assess the nutritional effects of a 12 weeks administration of the specific enteral nutrition (SEN) RealDiet®Renal pockets, as well as the impact on the patients' quality of life.
- Conditions
- Chronic Kidney Disease, Renal Failure Chronic Requiring Hemodialysis, Severe Malnutrition, Tolerance
- Trial name
- AL-EN-PHED (NCT01946841)
- Testing
- RealDiet®Renal
- Where
- France
- Sponsor
- Lactalis
Malnutrition, Pulmonary Disease, Chronic Obstructive
Nutritional Supplementation in Adults With Chronic Respiratory Disease
The purpose of this study is to determine whether nutritional support with a complete formula is effective to improve malnutrition and respiratory function in patients with chronic pulmonary disease compared to the standard…
- Conditions
- Malnutrition, Pulmonary Disease, Chronic Obstructive, Other Pulmonary Disease, Chronic Obstructive
- Trial name
- OFOS (NCT02102009)
- Testing
- Complete enteral formula, Dietary Advise
- Where
- Peru
- Volunteers
- 99 people
- Sponsor
- Laboratorios Ordesa
Malnutrition, Complication of Hemodialysis
Intradialytic Parenteral Nutrition in Hemodialysis Patients
Malnutrition is a major cause of death in chronic hemodialysis patients. Primary treatment of malnutrition in these patients is dietetic counseling, additional enteral nutrition and occasionally drug therapy.
- Trial name
- IDPNHD (NCT00501956)
- Testing
- Intradialytic Parenteral Nutrition (IDPN)
- Where
- Germany
- Volunteers
- 140 people
- Sponsor
- Fresenius Kabi
Malnutrition, Cancer
Impact of a New Plant-based High-energy Oral Nutritional Supplement on Nutritional Outcomes in Malnourished Patients
This study aims to compare nutritional outcomes in terms of percentage of weight gain between a new planted-based high-energy ONS and a standard high-energy ONS with animal protein (cow's mil protein) in patients at malnutrition…
- Conditions
- Malnutrition, Cancer, Inflammatory Bowel Diseases, Chronic Obstructive Pulmonary Disease (COPD)
- Trial name
- NCT06055543
- Testing
- Fortimel
- Where
- 6 sites in Spain
- Volunteers
- 140 people
- Sponsor
- Danone Specialized Nutrition
Secondary Hyperparathyroidism, Chronic Kidney Disease
Study to Assess Patient Management Practices and Quality of Life With Paricalcitol Capsules in the Treatment of Secondary Hyperparathyroidism in Stage 3-5 Chronic Kidney Disease Patients Not Yet on Dialysis
Paricalcitol capsules (Zemplar®) received marketing authorization in Sweden in late 2007 for the prevention and treatment of secondary hyperparathyroidism in patients with Stage 3 \& 4 Chronic Kidney Disease (CKD).
- Trial name
- CAPITOL (NCT01265992)
- Where
- 10 sites in Sweden
- Volunteers
- 50 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Deficiency, Vitamin C, Chronic Disease
A Long-term Observational Study to Describe the Use of Vitamin-C Injektopas® 7.5 g in Patients With Vitamin C Deficiency
The goal of this observational study is to learn more about the disease and the symptoms where the product will use and in which patient groups. Further on, it is interesting to know clinical pictures, the symptoms improve.
- Conditions
- Deficiency, Vitamin C, Chronic Disease, Acute Disease
- Trial name
- NCT06983847
- Where
- Austria
- Volunteers
- 1,000 people
- Sponsor
- Pascoe Pharmazeutische Praeparate GmbH
End-stage Renal Disease, Malnutrition; Protein
Impact of IDPN on Nutrition Markers in Patients Receiving ICHD
Evaluate the impact of intradialytic parenteral nutrition (IDPN) compounded with Clinisol, Prosol, and/or Clinolipid on albumin levels and weight in patients with end-stage renal disease (ESRD) undergoing in-center hemodialysis.
- Trial name
- NCT05439174
- Testing
- Intradialytic Parenteral Nutrition
- Where
- United States
- Volunteers
- 1,200 people
- Sponsor
- Patient Care America
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.
Chronic Kidney Diseases, Protein-Energy Malnutrition
Effect of a Specialized Oral Supplement on Nutritional Status and Quality of Life in Non-dialysis CKD
Patients whit chronic kidney disease (CKD) there is a high prevalence of nutritional disorders and negative changes in body composition, which is strongly associated with an increased risk of morbidity and mortality.
- Trial name
- NCT06576479
- Testing
- Nutritious Shake, Nutritional counseling
- Where
- Mexico
- Volunteers
- 50 people
- Sponsor
- NIN Institute
Vitamin C Deficiency, Acute Disease
A Long-term Study to Describe the Use of PASCORBIN® 7.5 g in Patients With Vitamin C Deficiency
The aim of this long-term observational study is the documentation of the use of PASCORBIN® 7.5 g in patients with vitamin C deficiency.
- Conditions
- Vitamin C Deficiency, Acute Disease, Chronic Disease
- Trial name
- NCT02422901
- Testing
- vitamin C
- Where
- Germany
- Volunteers
- 5,000 people
- Sponsor
- Pascoe Pharmazeutische Praeparate GmbH
Malnutrition, ESRD
ProStat Supplementation in Dialysis Patients
This is a long-term, randomized, placebo-controlled, double blind clinical study of a nutritional supplement, ProStat 64, in chronic hemodialysis patients with poor nutrition.
- Trial name
- NCT00435123
- Testing
- Nutritional Supplement ProStat 64 twice a day
- Where
- 6 sites in United States
- Volunteers
- 16 people
- Sponsor
- Fresenius Medical Care North America
Renal Osteodystrophy
12-month Study of AMG 073 in Renal Osteodystrophy
4 doses of AMG 073 or placebo over 52 weeks after a 30-day screening period. Throughout the study, labs will be drawn to measure analytes such as iPTH and corrected calcium.
- Trial name
- NCT00527085
- Testing
- AMG 073
- Volunteers
- 45 people
- Sponsor
- Amgen
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
ESRD
Influence of the PEPA Membrane on the Undernutrition Syndrome Inflammation in Chronic Hemodialysis
NutriPEPA2 is a randomized, single-blind, prospective, multicenter trial, in two parallel arms to confirm that the adsorbent PEPA membrane may decrease mortality related to inflammation and malnutrition encountered in HD or…
- Trial name
- NutriPEPA2 (NCT04185571)
- Testing
- PEPA
- Where
- 12 sites in France, Monaco
- Volunteers
- 106 people
- Sponsor
- Theradial