Clinical trials: Acidosis
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.
Distal Renal Tubular Acidosis
Study Evaluating Subjects With Distal Renal Tubular Acidosis
This is a phase 3, prospective, multicenter, randomized, double-blinded, placebo-controlled withdrawal study comparing the efficacy of ADV7103 versus placebo in preventing the development of metabolic acidosis in pediatric and…
- Trial name
- NCT03644706
- Testing
- ADV7103
- Where
- 8 sites in United States, Canada
- Volunteers
- 3 people
- Sponsor
- Advicenne Pharma
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
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.
Dyspnea, Lactic Acidosis
Effect of High Velocity/Hyperoxic Breathing Therapy on Blood Lactate Decline
The study will evaluate the impact of high velocity therapy (HVT) on reduction of work of breathing (as implied by breath frequency) and enhanced blood lactate decline during recovery from a Wingate-type Exercise test.
- Conditions
- Dyspnea, Lactic Acidosis, Muscle, Breathlessness
- Trial name
- NCT05984186
- Testing
- High Velocity Therapy
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Vapotherm, Inc.
MELAS
Phase 2a Study of IW-6463 in Adults Diagnosed With Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like Episodes (MELAS)
This is a single-arm study to evaluate safety and tolerability of oral IW-6463 in adults diagnosed with MELAS.
- Trial name
- NCT04475549
- Testing
- IW-6463 Tablets
- Where
- 5 sites in United States
- Volunteers
- 8 people
- Sponsor
- Tisento Therapeutics
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.
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
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