Distal renal tubular acidosis MedDRA version: 21.1 Level: PT Classification code 10038535 Term: Renal tubular acidosis System Organ Class: 10038359 - Renal and urinary disorders
Conditions
Interventions
Product Code: ADV7103-8mEq
Pharmaceutical Form: Prolonged-release granules
INN or Proposed INN: potassium citrate anhydrous
CAS Number: 6100-05-6
Other descriptive name: potassium citrate
tripotassium citrate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 267-
INN or Proposed INN: potassium hydrogen carbonate
CAS Number: 298-14-6
Other descriptive n
tripotassium citrate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 800-
INN or Proposed INN: potassium hydrogen carbonate
CAS Number: 298-14-6
Other descriptive n
Sponsors
Advicenne SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria for subjects who did not participate in Study B23CS: 1. Female or male subjects = 65 years of age at time of consent with the following stipulations: a. Subjects = 6 months of age must reside in Europe b. Subjects 6 months and 5.5 and serum bicarbonate > 18 mEq/L for subjects = 4 years old or > 17 mEq/L for subjects =65 years) yes F.1.3.1 Number of subjects for this age range 3
Exclusion criteria
Exclusion criteria: Exclusion criteria for subjects who did not participate in Study B23CS: 1. Female subject who is pregnant or lactating or has plans for pregnancy during the study; 2. Subject has evidence of proximal tubule dysfunction (eg, hypophosphatemia, low serum uric acid, glycosuria, or amino aciduria) unless the subject is 1.5x upper limit of normal (ULN) b. Serum potassium > 5.0 mEq/L or hypokalemia accompanied by clinical symptoms (eg, muscle cramps) or significant ECG changes (eg, T wave depression, U wave elevation) c. Estimated glomerular filtration rate (eGFR) ULN, except with known Gilbert's disease. 7. Subject has been hospitalized or had outpatient surgery (other than minor skin and dRTA disease-related procedures or ear tube placement) in the past 6 months or is planning surgery in the next 6 months; 8. In the opinion of the Investigator, the subject has a major medical or psychiatric condition (eg, significant cardiac disease, schizophrenia) or an unstable condition (eg, uncontrolled hypertension, asthma, diabetes, hypercholesterolemia, or cardiac disease) that would potentially interfere with the subject safely completing the study; 9. In the opinion of the Investigator, the subject has a history of difficulty taking oral medication and/or conditions that may hamper absorption of the study product (eg, any difficulty of swallowing, malabsorption, delayed gastric emptying, esophageal compression, intestinal obstruction, or other chronic gastrointestinal disease); 10. Self-reported or parent/guardian reported alcohol abuse or drug abuse within the past 12 months; 11. Subject is a solid organ or bone marrow transplant recipient; 12. Subject has a history of malignancy within 5 years prior to the screening visit, except for localized skin or cervical carcinoma; or 13. Subject is known to have an allergy to any ADV7103 constituents.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the long term safety and tolerability of ADV7103 in subjects with primary distal renal tubular acidosis (dRTA).;Secondary Objective: •Evaluate the long term efficacy of ADV7103 in maintaining targeted serum bicarbonate levels and preventing metabolic acidosis in dRTA subjects; •Evaluate the long term efficacy of ADV7103 in maintaining targeted serum potassium levels in dRTA subjects; •Evaluate the effects of ADV7103 on hypocitraturia; •Evaluate the effects of ADV7103 on hypercalciuria.;Primary end point(s): Number/proportion of subjects presenting with ADV7103 treatment related adverse events (AEs) during the study, by severity grade.;Timepoint(s) of evaluation of this end point: 36 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Number/proportion of subjects with serum bicarbonate levels in the normal range for age during = 80% of study encounters (study visits and remote interactions); • Number/proportion of subjects with serum potassium levels in the normal range for age during = 80% of study encounters (study visits and remote interactions); • Number/proportion of subjects with a serum potassium level 8.5 • Number/proportion of subjects with positive crystalluria • Number/proportion of subjects adherent to prescribed ADV7103 treatment: less than 50%, at least 50%, at least 75%, at least 90%, and more than 110%, of the time (based ADV7103 accountability data coupled with ADV7103 paper dosing diary data). ;Timepoint(s) of evaluation of this end point: 36 months | — |
Countries
Canada, Germany, United States
Contacts
Public ContactClinical & regulatory affairs
Advicenne SA
Outcome results
None listed