Clinical trials: Processes, Metabolic
Chronic Kidney Disease, Dialysis
Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia
The primary objective of this study is to demonstrate the long-term safety and tolerability of MCI-196 in the subjects with stage V chronic kidney disease on dialysis with hyperphosphatemia.
- Conditions
- Chronic Kidney Disease, Dialysis, Hyperphosphatemia
- Trial name
- NCT00772382
- Testing
- MCI-196
- Where
- 21 sites in United States, Canada
- Volunteers
- 116 people
- Sponsor
- Tanabe Pharma Corporation
Urea Cycle Disorder
A Study of the Safety, Efficacy and Pharmacokinetics of Glycerol Phenylbutyrate in Pediatric Subjects Under 2 Years of Age With Urea Cycle Disorders
This is an open-label study consisting of a transition period to RAVICTI, followed by a safety extension period for at least 6 months and up to 24 months of treatment with RAVICTI, depending on age at enrollment.
- Trial name
- NCT02246218
- Testing
- RAVICTI
- Where
- 17 sites in United States, Canada
- Volunteers
- 27 people
- Sponsor
- Amgen
Urea Cycle Disorders
To Evaluate the Safety of Long-term Use of HPN-100 in the Management of Urea Cycle Disorders (UCDs)
This was an open-label, long-term safety study of HPN-100 (RAVICTI; glycerol phenylbutyrate) in participants with a urea cycle disorder (UCD) who completed the safety extensions of HPN-100-005 (NCT00947544; HPN-100-005SE)…
- Trial name
- NCT01257737
- Testing
- HPN-100
- Where
- 16 sites in United States, Canada
- Volunteers
- 88 people
- Sponsor
- Amgen
Chronic Kidney Disease, Dialysis
A Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia
This is a PIII multi-center, open-label, flexible dose, long-term safety study, that in conjunction with the E07(NCT00416520), E08(NCT00542386) and E09(NCT00451295) studies will allow exposure to MCI-196 for up to 52 weeks
- Conditions
- Chronic Kidney Disease, Dialysis, Hyperphosphatemia
- Trial name
- NCT00542815
- Testing
- MCI-196, Another Phosphate binder (Sevelamer)
- Where
- 115 sites in Austria, Czechia and 13 more
- Volunteers
- 632 people
- Sponsor
- Tanabe Pharma Corporation
Hunter Syndrome
A Safety and Dose Ranging Study of Idursulfase (Intrathecal) Administration Via an Intrathecal Drug Delivery Device in Pediatric Patients With Hunter Syndrome Who Have Central Nervous System Involvement and Are Receiving Treatment With Elaprase®
Elaprase (idursulfase), a large molecular protein, is not expected to cross the blood brain barrier at therapeutic levels when administered intravenously.
- Trial name
- NCT00920647
- Testing
- Control, Idursulfase IT (1 mg), Idursulfase IT (10 mg)
- Where
- 3 sites in United States, United Kingdom
- Volunteers
- 16 people
- Sponsor
- Shire
Hunter Syndrome
Study of Intrathecal Idursulfase-IT Administered in Conjunction With Elaprase® in Pediatric Patients With Hunter Syndrome and Early Cognitive Impairment
Study HGT-HIT-094 is a multicenter study designed to determine the effect on clinical parameters of neurodevelopmental status of monthly IT administration of idursulfase-IT 10 mg for 12 months in pediatric patients with Hunter…
- Trial name
- AIM-IT (NCT02055118)
- Testing
- idursulfase-IT, No IT treatment
- Where
- 9 sites in United States, Australia and 5 more
- Volunteers
- 58 people
- Sponsor
- Shire
Atrial Fibrillation, Obesity
Effectiveness And Safety Of Oral Anticoagulants Among Obese Patients With Non-Valvular A-Fib In VA Patients With Medicare
The overall objective of this analysis is to understand patient characteristics, the use of treatment, and clinical outcomes among obese (overweight) and severely obese patients with non-valvular atrial fibrillation (NVAF) who…
- Conditions
- Atrial Fibrillation, Obesity, Anticoagulants
- Trial name
- NCT04681482
- Testing
- Apixaban
- Where
- United States
- Volunteers
- 107,383 people
- Sponsor
- Pfizer
Hypotension
Efficacy Study of a Facemask Device to Treat Hypotension
The purpose of this study is to determine if the impedance threshold device (ITD) attached to a facemask can increase blood pressure in patients who present to the emergency department with hypotension secondary to hypovolemia.
- Trial name
- NCT00256724
- Testing
- Impedance Threshold Device
- Where
- United States
- Volunteers
- 47 people
- Sponsor
- Advanced Circulatory Systems
Mucopolysaccharidosis II, MPS II
Ascending Dose Study of Genome Editing by the Zinc Finger Nuclease (ZFN) Therapeutic SB-913 in Subjects With MPS II
The purpose of the study is to evaluate the safety, tolerability and effect on leukocyte and plasma Iduronate 2-Sulfatase (IDS) enzyme activity of ascending doses of SB-913.
- Trial name
- NCT03041324
- Testing
- SB-913
- Where
- 5 sites in United States
- Volunteers
- 9 people
- Sponsor
- Sangamo Therapeutics
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.
Anemia, Iron-Deficiency, Kidney Failure, Chronic
Effect of Ferrlecit® Versus Oral Iron on Iron Deficient Chronic Kidney Disease (CKD) Patients Receiving Erythropoietic Agents
This study compares the effect of Ferrlecit® (a form of intravenous iron) to ferrous sulfate (a form of oral iron) in treating anemia and iron deficiency in chronic kidney disease patients who are receiving erythropoietic agents…
- Trial name
- NCT00224042
- Testing
- Sodium Ferric Gluconate complex in sucrose, Ferrous sulfate tablets
- Where
- 24 sites in United States, Puerto Rico
- Volunteers
- 52 people
- Sponsor
- Watson Pharmaceuticals
Heart Failure
Evaluation of Patiromer Titration in Heart Failure Patients With Chronic Kidney Disease
The purpose of this study was to evaluate the feasibility of individualized titration of patiromer according to serum potassium.
- Trial name
- NCT01130597
- Testing
- patiromer, spironolactone
- Where
- 13 sites in Georgia, Slovenia
- Volunteers
- 63 people
- Sponsor
- Relypsa, Inc.
Iron Deficiency Anaemia, Iron Deficiency Anemia
Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for Treatment of Iron Deficiency Anemia in Non-Dialysis-Dependent Chronic Kidney Disease
Evaluation of safety and efficacy of iron isomaltoside/ferric derisomaltose compared with iron sucrose, in subjects with both non-dialysis-dependent chronic kidney disease (NDD-CKD) and iron deficiency anaemia (IDA).
- Conditions
- Iron Deficiency Anaemia, Iron Deficiency Anemia, Chronic Kidney Disease
- Trial name
- NCT02940860
- Testing
- Iron isomaltoside/ferric derisomaltose, Iron sucrose
- Where
- 141 sites in United States
- Volunteers
- 1,538 people
- Sponsor
- Pharmacosmos A/S
Fibromyalgia
Safety Study of DS-5565 for Treatment of Fibromyalgia Pain in Subjects With Chronic Kidney Disease
DS-5565 (mirogabalin) is being studied as treatment for fibromyalgia (FM) pain. Because it is excreted through the kidneys, people who have reduced kidney function will not process the drug as well as with those with normal…
- Trial name
- NCT02496884
- Testing
- DS-5565
- Where
- 39 sites in United States, Bulgaria and 6 more
- Volunteers
- 56 people
- Sponsor
- Daiichi Sankyo
Gout, Hyperuricemia
Open Label PK, PD and DDI of Dotinurad and Allopurinol in Gout Patients With Hyperuricemia
A open label multi-center 3-period multidose, PK/PD and drug-drug interaction (DDI) study to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of 7 days of treatment with two doses of dotinurad monotherapy, and to…
- Trial name
- NCT06056570
- Testing
- dotinurad, dotinurad + allopurinol, allopurinol
- Where
- 4 sites in United States
- Volunteers
- 20 people
- Sponsor
- Urica Therapeutics Inc.
Inherited Mitochondrial Disease, Including Leigh Syndrome
Open-Label, Dose-Escalating Study Assessing Safety, Tolerability, Efficacy, of RP103 in Mitochondrial Disease
To evaluate safety, tolerability and efficacy of cysteamine bitartrate delayed-release capsules (RP103) administered at a target maintenance dose of 1.3 g/m²/day in two divided doses, every 12 hours, for up to 6 months in…
- Trial name
- MITO-001 (NCT02023866)
- Testing
- Cysteamine Bitartrate
- Where
- 5 sites in United States
- Volunteers
- 36 people
- Sponsor
- Amgen
Iron Deficiency Anemia Treatment, Chronic Kidney Disease(CKD)
Compare Efficacy/Safety of Repeat Doses of Ferumoxytol With Iron Sucrose in CKD Subjects With IDA and on Hemodialysis
The objectives of this study are to compare the efficacy and safety of repeat doses of intravenous (IV) ferumoxytol with IV iron sucrose for the treatment of IDA in subjects with hemodialysis-dependent CKD.
- Trial name
- NCT01227616
- Testing
- Ferumoxytol, Iron Sucrose
- Where
- 43 sites in United States, Canada and 1 more
- Volunteers
- 296 people
- Sponsor
- AMAG Pharmaceuticals, Inc.
Hepatic Encephalopathy, Cirrhosis
The Safety/Efficacy of Rifaximin With/Without Lactulose in Participants With A History of Recurrent Hepatic Encephalopathy
The purpose of the study is to evaluate if rifaximin alone or rifaximin plus lactulose delays the onset of hepatic encephalopathy (HE) in participants with cirrhosis who have had a previous episode of HE.
- Trial name
- NCT01842581
- Testing
- Rifaximin, Lactulose
- Where
- 43 sites in United States
- Volunteers
- 222 people
- Sponsor
- Bausch Health Americas, Inc.
Hepatic Cirrhosis, Hepatic Encephalopathy (HE)
MNK6106 for Liver Disease (Hepatic Cirrhosis) That in the Past Has Affected the Brain (Hepatic Encephalopathy)
The main reason for this study is to see how the study drug interacts with the body. It will compare different doses of the study drug with a drug already in use.
- Trial name
- NCT03712280
- Testing
- MNK6106, Rifaximin
- Where
- 5 sites in United States, Puerto Rico
- Volunteers
- 50 people
- Sponsor
- Mallinckrodt
Renal Insufficiency, Chronic, Iron-Deficiency Anemia
Study With Oral Ferric Maltol for the Treatment of Iron Deficiency Anemia in Subjects With Chronic Kidney Disease
To evaluate the efficacy of oral ferric maltol compared with placebo in the treatment of IDA in subjects with CKD
- Trial name
- AEGIS-CKD (NCT02968368)
- Testing
- Ferric maltol
- Where
- 27 sites in United States
- Volunteers
- 167 people
- Sponsor
- Shield Therapeutics