Clinical trials: Metabolic Acidosis
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
Acidosis
Evaluation of TRC101 in Subjects With Chronic Kidney Disease and Metabolic Acidosis
This was a double-blind, placebo-controlled, parallel-design, 6-arm, fixed dose study. The study enrolled 135 adult male and female subjects with Stage 3 or 4 chronic kidney disease and low serum bicarbonate levels.
- Trial name
- NCT02809183
- Testing
- TRC101
- Where
- 5 sites in Bulgaria, Georgia
- Volunteers
- 135 people
- Sponsor
- Tricida, Inc.
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
Diabetes Mellitus, Ketosis, Diabetic
StatStrip Glucose/Ketone Meter System Ketone Evaluation
The Nova StatStrip Glucose / Ketone Meter System is a fast, simple, whole blood system that can be used to quantify both glucose and ketones using two distinct test strips.
- Trial name
- NCT05118061
- Testing
- Ketone
- Where
- 3 sites in United States, Germany
- Volunteers
- 173 people, healthy volunteers welcome
- Sponsor
- Nova Biomedical
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
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.
Hypoxia, Ketosis
Ketone Esters for Optimization of Cognitive Performance in Hypoxia
This study will investigate the effects of ketone ester drinks on cognitive performance in hypoxia.
- Trial name
- NCT03659825
- Testing
- Ketone Ester, Hypoxic exposure
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- HVMN Inc
Metabolic Acidosis
Long-term Safety Extension to Study TRCA-301
This study is a 40-week, blinded, placebo-controlled extension of Study TRCA-301 (NCT03317444). Eligible subjects who complete the 12-week treatment period in Study TRCA-301 have the option to participate in this extension study…
- Trial name
- NCT03390842
- Testing
- TRC101
- Where
- 29 sites in United States, Bulgaria and 5 more
- Volunteers
- 196 people
- Sponsor
- Tricida, Inc.
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
Shock, Hemorrhagic, Shock, Traumatic
Phase IIa Study of MP4OX in Traumatic Hemorrhagic Shock Patients
MP4OX is a novel oxygen therapeutic agent specifically developed to perfuse and oxygenate tissue at risk for ischemia and hypoxia.
- Conditions
- Shock, Hemorrhagic, Shock, Traumatic, Acidosis, Lactic
- Trial name
- NCT01004198
- Testing
- MP4OX, Ringers Lactate solution
- Where
- 13 sites in France, Germany and 2 more
- Volunteers
- 51 people
- Sponsor
- Sangart
Renal Tubular Acidosis, Distal, With Hemolytic Anemia
A Study Of Mircera In Patients With Kidney Disease Who Are Not On Dialysis
This open-label, non-randomized, retrospective-prospective, non-interventional study will evaluate the efficacy and safety of Mircera in patients with stage III-IV chronic kidney disease (CKD) not on dialysis.
- Trial name
- NCT02490514
- Testing
- No intervention
- Where
- 10 sites in Serbia
- Volunteers
- 153 people
- Sponsor
- Hoffmann-La Roche
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
Propionic Acidemia
A Study to Assess the Long-term Safety and Clinical Activity of mRNA-3927 in Participants Previously Enrolled in the mRNA-3927-P101 Study
The main purpose of this study is to evaluate the long-term safety of mRNA-3927 administered to participants with propionic acidemia (PA) who have previously participated in Study mRNA-3927-P101 (NCT04159103).
- Trial name
- NCT05130437
- Testing
- mRNA-3927
- Where
- 22 sites in United States, Canada and 6 more
- Volunteers
- 50 people
- Sponsor
- ModernaTX, Inc.
Metabolic Acidosis
Evaluation of TRC101 in Subjects With Metabolic Acidosis Associated With Chronic Kidney Disease
This is a multicenter, double-blind, placebo-controlled, parallel-design study. The study will enroll approximately 210 adult male and female subjects with stage 3 or 4 chronic kidney disease and metabolic acidosis.
- Trial name
- NCT03317444
- Testing
- TRC101
- Where
- 44 sites in United States, Bulgaria and 6 more
- Volunteers
- 217 people
- Sponsor
- Tricida, Inc.
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
Healthy Volunteers and Diabetes Participants
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PAL-119 in Healthy Volunteers and Adult Participants With Type 1 or Type 2 Diabetes
This is a Phase 1/2 randomized study of oral doses of PAL-119 in healthy volunteers and participants with diabetes.
- Trial name
- NCT07901595
- Testing
- PAL-119
- Volunteers
- 147 people, healthy volunteers welcome
- Sponsor
- Paulex Bio Inc.
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
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
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.
Shock, Hemorrhagic, Shock, Traumatic
Phase IIb Study of MP4OX in Traumatic Hemorrhagic Shock Patients
MP4OX is a novel oxygen therapeutic agent being developed as an ischemic rescue therapy to enhance perfusion and oxygenation of tissues at risk during hemorrhagic shock. MP4OX is a pegylated hemoglobin-based colloid.
- Conditions
- Shock, Hemorrhagic, Shock, Traumatic, Acidosis, Lactic
- Trial name
- NCT01262196
- Testing
- MP4OX, Saline
- Where
- 40 sites in Australia, Austria and 12 more
- Volunteers
- 348 people
- Sponsor
- Sangart