Clinical trials: Acidosis
Mitochondrial Encephalopathy, Lactic Acidosis and Stroke-Like Episodes (MELAS Syndrome)
A Phase 2b Study of Zagociguat in Patients With MELAS
PRIZM is a Phase 2b randomized, double-blind, placebo-controlled, 3-treatment, 2-period, crossover study evaluating the efficacy and safety of oral zagociguat 15 and 30 mg vs.
- Trial name
- PRIZM (NCT06402123)
- Testing
- zagociguat 15mg, zagociguat 30mg
- Where
- 20 sites in United States, Australia and 4 more
- Volunteers
- 43 people
- Sponsor
- Tisento Therapeutics
Tyrosinemia, Type I, Tyrosinemia, Type II
Acceptability/Tolerance of Protein Substitutes in Tablet Form for the Dietary Management of Rare Aminoacidopathies
The purpose of this prospective, observational study is to evaluate the tolerability and acceptability of Zero minis, a range of protein substitute tablets for use in the dietary management of children with either TYROSINAEMIA…
- Conditions
- Tyrosinemia, Type I, Tyrosinemia, Type II, Tyrosinemia, Type III, Alkaptonuria
- Trial name
- ZeroMinisMR (NCT06298292)
- Testing
- Zero minis (range of protein substitutes in tablet form)
- Volunteers
- 15 people
- Sponsor
- metaX Institut fuer Diatetik GmbH
Alzheimer's Disease
AC-1204 Long-term Efficacy Response Trial (ALERT Protocol)
The study will evaluate the safety \& efficacy of AC-1204, a ketogenic compound, administered orally on a daily basis for 6 months.
- Trial name
- ALERT (NCT01211782)
- Testing
- caprylic triglyceride, long-chain triglyceride
- Where
- United States
- Sponsor
- Cerecin
EFFECT OF ADV7103 ON GASTRIC PH, Distal Renal Tublular Acidosis
A Phase 1 Study, to Evaluate the Effect of ADV7103 on Gastric pH Under Fed and Fasting Conditions in Adult Healthy Participants.
This was a Phase 1, single-center, randomized, controlled, Latin-square, open-label study to evaluate the effect of ADV7103 on the gastric pH, after administering a single oral dose of ADV7103 in healthy adult participants under…
- Trial name
- B06 (NCT07446881)
- Testing
- ADV7103
- Where
- France
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Advicenne Pharma
Trauma, Hemorrhagic Shock
Phase 2c Dose Comparison Study of MP4OX in Trauma
MP4OX is being developed as an ischemic rescue therapy to perfuse and oxygenate tissues at risk during hemorrhagic shock. MP4OX is a pegylated hemoglobin-based colloid designed to improve perfusion and target delivery of oxygen…
- Conditions
- Trauma, Hemorrhagic Shock, Lactic Acidosis
- Trial name
- NCT01973504
- Testing
- MP4OX, Control
- Where
- 31 sites in Australia, Belgium and 9 more
- Sponsor
- Sangart
Lung Disease, Hypoxemia
Inhaled Nitric Oxide in Neonates With Elevated A-a DO2 Gradients Not Requiring Mechanical Ventilation
The purpose of this pilot study is to evaluate whether administration of nitric oxide (NO)gas by oxygen hood at 20 ppm significantly increases PaO2, as compared to placebo gas (oxygen), within one hour of initiation and with no…
- Conditions
- Lung Disease, Hypoxemia, Respiratory Acidosis
- Trial name
- NCT00041548
- Testing
- nitric oxide for inhalation, Oxygen
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Mallinckrodt
Ketosis, Epilepsy
Market Research - Acceptability Study for New MCT Fat Products
This is a market research, observational study to evaluate the tolerability and acceptability of MCT supplements for young children, young people and adults with intractable epilepsy, GLUT-1 or PDHD from 3 years to adulthood.
- Conditions
- Ketosis, Epilepsy, Fatty Acid Oxidation Disorder, Malabsorption
- Trial name
- NCT04309214
- Testing
- MCT fats
- Where
- United Kingdom
- Volunteers
- 12 people
- Sponsor
- Dr. Schär AG / SPA
Mitochondrial Diseases, Mitochondrial DNA tRNALeu(UUR) m.3243A<G Mutation
The KHENEREXT Study
This is an open-label, multi-centre study in subjects with a genetically confirmed mitochondrial deoxyribonucleic acid (DNA) transfer ribonucleic acid (tRNA)Leu(UUR) m.3243A>G mutation who completed study KH176-202.
- Conditions
- Mitochondrial Diseases, Mitochondrial DNA tRNALeu(UUR) m.3243A<G Mutation, Maternally Inherited Diabetes and Deafness (MIDD), Mitochondrial Encephalomyopathy, Lactic Acidosis and Stroke Like Episodes (MELAS)
- Trial name
- NCT04604548
- Testing
- Oral administration of 100 mg KH176 twice daily
- Where
- 4 sites in Denmark, Germany and 2 more
- Volunteers
- 11 people
- Sponsor
- Khondrion BV
Alzheimer's Disease
Effects of Triglycerides on Age-Related Cognitive Function Decline in Older Subjects
This is a single centre, 2 part study in older subjects. Part 1 (Pharmacokinetic [PK] Assessment) is a double blind, randomized, placebo-controlled 4-period crossover study investigating the PK profile of four different doses of…
- Trial name
- NCT01702480
- Testing
- GSK2981710
- Where
- United Kingdom
- Volunteers
- 116 people
- Sponsor
- GlaxoSmithKline
Mitochondrial Diseases, Maternally Inherited Diabetes and Deafness (MIDD)
KHENERFIN Study: A Trial to Evaluate the Efficacy and Safety of Sonlicromanol in Primary Mitochondrial Diseases
The KHENERFIN study aims to determine whether the study medicine, sonlicromanol, is able to reduce symptoms of fatigue and the impact of fatigue on daily life, and whether sonlicromanol is able to improve physical abilities of…
- Conditions
- Mitochondrial Diseases, Maternally Inherited Diabetes and Deafness (MIDD), Mitochondrial Encephalomyopathy, Lactic Acidosis and Stroke-like Episodes (MELAS), Mitochondrial DNA tRNALeu(UUR) m.3243A<G Mutation
- Trial name
- KH176-301 (NCT06451757)
- Testing
- Sonlicromanol
- Where
- 10 sites in United States, Denmark and 5 more
- Volunteers
- 220 people
- Sponsor
- Khondrion BV
Propionic Acidemia
Open-Label Study of mRNA-3927 in Participants With Propionic Acidemia
This 3-part, Phase 1/2 study is designed to characterize the safety, tolerability, and pharmacological activity (as assessed by biomarker measurements) and to determine the selected dose of mRNA-3927 in participants with…
- Trial name
- NCT04159103
- Testing
- mRNA-3927
- Where
- 35 sites in United States, Canada and 6 more
- Volunteers
- 77 people
- Sponsor
- ModernaTX, Inc.
Hyperkalaemia, Metabolic Acidosis
Study of the Effect of SZC on Serum Potassium and Serum Bicarbonate in Patients With Hyperkalemia and Metabolic Acidosis Associated With Chronic Kidney Disease
The main objective of this study is to evaluate the efficacy of SZC as compared to placebo in maintaining normal sK+ in patients with hyperkalemia and metabolic acidosis associated with CKD
- Conditions
- Hyperkalaemia, Metabolic Acidosis, Chronic Kidney Disease
- Trial name
- NEUTRALIZE (NCT04727528)
- Testing
- Sodium zirconium cyclosilicate
- Where
- 30 sites in United States, Puerto Rico
- Volunteers
- 39 people
- Sponsor
- AstraZeneca
Urinary Tract Infections, Proteinuria
Scanadu Urine Device Validation Study Protocol
This study will test Scanadu Urine Device for clinical performance and usability.
- Conditions
- Urinary Tract Infections, Proteinuria, Ketone Urine, Hematuria
- Trial name
- NCT02973178
- Testing
- Scanadu Urine Device
- Where
- 2 sites in United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Scanadu, Inc.
CKD, Metabolic Acidosis
A Study to Evaluate the Efficacy and Safety of Veverimer for the Treatment of Metabolic Acidosis
The purpose of this study is is to evaluate the efficacy and safety of veverimer in treating adults with moderate-to-severe chronic kidney disease (CKD) and metabolic acidosis.
- Trial name
- NCT07355062
- Testing
- Veverimer
- Where
- 28 sites in United States
- Volunteers
- 150 people
- Sponsor
- Renibus Therapeutics, Inc.
Hypercapnic Respiratory Failure, Chronic Obstructive Pulmonary Disease
Clinical Stabilization of Hypercapnia: NIPPV v HVNI
This study will evaluate the ability of High Velocity Nasal Insufflation [HVNI] to effect ventilation and related physiologic responses in hypercapnic patients when compared to noninvasive positive pressure ventilation [NIPPV].
- Conditions
- Hypercapnic Respiratory Failure, Chronic Obstructive Pulmonary Disease, Dyspnea, Hypercapnic Acidosis
- Trial name
- HYPERACT (NCT04709562)
- Testing
- High Velocity Nasal Insufflation (HVNI), Noninvasive Positive Pressure Ventilation (NIPPV)
- Where
- 7 sites in United States
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Vapotherm, Inc.
Metabolic Acidosis, Chronic Kidney Disease
Evaluation of Effect of TRC101 on Progression of Chronic Kidney Disease in Subjects With Metabolic Acidosis
The purpose of this study is to evaluate the effect of TRC101 on the progression of chronic kidney disease (CKD) and to evaluate the safety profile of TRC101 in CKD patients with metabolic acidosis.
- Trial name
- VALOR-CKD (NCT03710291)
- Testing
- TRC101
- Where
- 203 sites in United States, Albania and 32 more
- Volunteers
- 1,480 people
- Sponsor
- Tricida, Inc.
Ketosis
Comparison Between Breath Acetone and Blood Beta-Hydroxybutyrate
Subjects will provide blood and breath samples to evaluate the relationship between breath acetone and two blood-bound species: beta-hydroxybutyrate and glucose.
- Trial name
- NCT03299543
- Testing
- LEVL (Medamonitor)
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- Medamonitor
Diabetes Mellitus - Type 1, Diabetes Mellitus - Type 2
The BRIGHT Study (Device Name: HALO System)
The purpose of the BRIGHT study is to evaluate safety and performance of the HALO SYSTEM in subjects with diabetes mellitus. The primary objectives of this clinical investigation are 1) the evaluation of sensor's performance by…
- Conditions
- Diabetes Mellitus - Type 1, Diabetes Mellitus - Type 2, Diabetes Mellitus, Ketoacidosis, Diabetic
- Trial name
- NCT07745998
- Testing
- The HALO System
- Volunteers
- 12 people
- Sponsor
- Indigo Diabetes NV
Metabolic Acidosis
Meglimine Sodium Succinate for Correction of Metabolic Acidosis in Critically Ill Patients
An acid-base imbalance, called metabolic acidosis (acid-base disorder lasting from several minutes to several days, caused by a decrease in serum bicarbonate ion (HCO3) concentration), is often observed in critically ill patients…
- Trial name
- NCT05147051
- Testing
- Meglumine Sodium Succinate
- Where
- 6 sites in Russia
- Volunteers
- 140 people
- Sponsor
- POLYSAN Scientific & Technological Pharmaceutical Company
Mitochondrial Diseases
A Long-term Extension of Study RP103-MITO-001 (NCT02023866) to Assess Cysteamine Bitartrate Delayed-release Capsules (RP103) in Children With Inherited Mitochondrial Disease
A long-term extension study to assess the safety, tolerability and efficacy of cysteamine bitartrate delayed-release capsules (RP103) in children with inherited mitochondrial diseases who previously enrolled into study…
- Trial name
- NCT02473445
- Testing
- Cysteamine Bitartrate
- Where
- 5 sites in United States
- Volunteers
- 22 people
- Sponsor
- Amgen