Thiamine as Adjunctive Therapy for Diabetic Ketoacidosis
Diabetic KetoacidosisThis is a randomized, double-blind, placebo-controlled trial to determine if administration of intravenous thiamine will lead to quicker resolution of acidosis in patients admitted to the hospital with diabetic ketoacidosis. The investigators will secondarily investigate whether thiamine improves cellular oxygen consumption, shortens intensive care unit (ICU) and hospital stay or decreases hospital resource utilization.
SODium BICarbonate for Metabolic Acidosis in the ICU
Metabolic AcidosisShockThis trial aims to assess if, among adults in the ICU with metabolic acidosis, an infusion of sodium bicarbonate diluted in 5% dextrose, compared with an infusion of 5% dextrose, reduces Major Adverse Kidney Events within 30 days of randomization.
Study of HST5040 in Subjects With Propionic or Methylmalonic Acidemia
Methylmalonic AcidemiaPropionic AcidemiaThis is an interventional study to assess the safety, PK, and efficacy of HST5040 in 12 subjects - 6 with Methylmalonic Acidemia (MMA) and 6 with Propionic Acidemia (PA). The study consists of 3 parts: Part A: Open-label, within-subject, dose escalation study in PA and MMA subjects ≥ 2 years old to identify a safe and pharmacologically active (optimal) dose of HST5040 for use in Part B. Subjects will continue in a Part A open-label extension until all subjects complete Part A and the optimal dose of HST5040 is identified for use in Part B. Part B: 6-month, randomized, double-blind, placebo-controlled, 2-period crossover in the same subjects from Part A to evaluate safety and efficacy of the optimal dose of HST5040 in addition to standard of care (SoC). Part C: open-label long-term extension study in PA and MMA subjects ≥ 2 years old (N = approximately 12, 6 each) to evaluate the long-term safety and efficacy of the optimal dose of HST5040. This study will determine whether HST5040 can improve levels of disease-associated toxins that accumulate in patients with PA and MMA.
Reducing Dietary Acid With Food Versus Oral Alkali in People With Chronic Kidney Disease (ReDACKD)...
Chronic Kidney DiseasesMetabolic AcidosisMetabolic acidosis is a common problem that occurs with worsening chronic kidney disease. Dietary acid can build up when the kidneys are not working well. This can be associated with a higher risk of worsening kidney function and death. The usual treatment is a medication called sodium bicarbonate which works to balance the acids in the body. The medication however often does not work and causes side effects. Consumption of alkalizing fruit and vegetables may work as a treatment for metabolic acidosis. This trial is being done to see if fruit and vegetables, provided via home delivery, can become a viable management for metabolic acidosis in patients with chronic kidney disease.
ADVOS® Versus CVVHD in Metabolic or Mixed Acidosis
Metabolic AcidosisThe aim of the study is to investigate the effects of ADVOS® therapy in critically ill patients with acute kidney injury, necessity of renal replacement therapy and acidosis. The investigators aim at assessing superiority of ADVOS® versus CVVHD for the primary outcome hours alive with normal pH (arterial pH ≤ 7,35) until 24 hours in a modified intention-to-treat analysis (mITT: replacement if dropped out before treatment start).
Effect of Alkali Therapy on Vascular and Graft Function in Kidney Transplant Recipients
Metabolic AcidosisKidney Transplant; Complications1 moreLower serum bicarbonate levels, even within the normal laboratory range, in kidney transplant recipients (KTRs) are associated with an increased risk of graft loss, cardiovascular events and mortality. Because acid retention is common in KTRs, it is plausible that alkali therapy in KTRs may also result in improved vascular and graft function. The investigators will perform a randomized, double-blinded, placebo-controlled, 12 month study in 120 KTRs to examine the effect of sodium bicarbonate therapy on surrogate markers of CVD and graft function. The overall hypothesis is that treatment with bicarbonate will improve indicators of vascular and graft function in KTRs by decreasing complement activation.
Reduction of Metabolic Acidosis in Patients With Chronic Kidney Disease in Stage 4 and 5
Kidney DiseasesMetabolic Acidosis3 moreThis clinical trial aims to investigate and test the effect of an acid/base diet in chronic kidney disease (CKD) patients, CKD stage 4 and 5. The trial is guided by the hypothesis that an acid/base diet will reduce the degree of acidosis and simultaneously reduce the need for bicarbonate supplements.
Open-Label Study of mRNA-3927 in Participants With Propionic Acidemia
Propionic AcidemiaThis First-in-Human (FIH) Phase 1/2 study will evaluate the safety and pharmacological activity of mRNA-3927 in participants 1 year of age and older with genetically confirmed propionic acidemia (PA). The study is designed to characterize baseline biomarker levels followed by assessment of safety, pharmacokinetics (PK), and pharmacodynamics (PD) of different doses of mRNA-3927 in participants affected by PA as part of the Dose Optimization phase.
A First in Human, Dose Escalation Study to Evaluate the Safety and Tolerability of BBP-671 in Healthy...
Healthy VolunteersPropionic Acidemia2 moreThe purpose of this study is to assess the safety, tolerability, PK and PD of BBP-671 in healthy volunteers and patients with Propionic Acidemia or Methylmalonic Acidemia.
A Study to Assess Safety, Pharmacokinetics, and Pharmacodynamics of mRNA-3705 in Participants With...
Methylmalonic AcidemiaThis is a study of mRNA-3705 in participants with isolated elevated methylmalonic acid (MMA) due to methylmalonyl-coenzyme A (CoA) mutase (MUT) deficiency. The main goal of the study is to assess safety, pharmacokinetics, and pharmacodynamics of mRNA-3705.