Extension Study in Primary Distal Renal Tubular Acidosis (NCT03831152) | Clinical Trial Compass
WithdrawnPhase 3
Extension Study in Primary Distal Renal Tubular Acidosis
Stopped: No patients enrolled. Study no longer required due to completion of long term safety study in the EU.
United States0Started 2023-12-20
Plain-language summary
Open-label study involving longitudinal assessment of the continued safety, tolerability, and efficacy of ADV7103 in maintaining targeted serum bicarbonate levels, preventing metabolic acidosis, and preventing hypokalemia in the following groups of subjects with primary dRTA:
1. subjects who participated in Study B23CS and were adherent to the protocol;
2. subjects ≥ 6 months of age who are living in Europe and did not participate in Study B23CS; and
3. infants younger than 6 months of age
Who can participate
Age range
4 Months – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Female or male subjects ≤ 65 years of age at time of consent with the following stipulations:
. Subjects ≥ 6 months of age must reside in Europe
. Subjects \< 6 months of age must reside in the United States, Canada, or Europe;
. Subjects \< 6 months of age must be able to swallow (not suck) solid food without difficulty;
. Subject presents with a previous diagnosis of primary dRTA;
. Subject ≥ 6 months of age requires ≥ 0.9 mEq/kg/day of alkali therapy to maintain serum bicarbonate levels above the LLN;
. Urine pH \> 5.5 and serum bicarbonate \> 18 mEq/L for subjects ≥ 4 years old or \> 17 mEq/L for subjects \< 4 years old on alkali therapy and potassium supplementation (if indicated) on at least one occasion for each within 6 months;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The Safety of ADV7103 will be assessed by evaluating the frequency of Treatment-Emergent Adverse events as compared to placebo
. European subjects must be included in a social health insurance system and/or in compliance with the recommendations of the national law in force relating to biomedical research;
Exclusion criteria
. Female subject who is pregnant or lactating or has plans for pregnancy during the study; or
. Subject requires therapy with potassium sparing diuretics, angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, trimethoprim, drospirenone and other progestins, nephrotoxic antibiotics, penicillins, tacrolimus, or medications known to delay gastric emptying or otherwise interfere with absorption of study product.
. Female subject who is pregnant or lactating or has plans for pregnancy during the study;
. Subject has evidence of proximal tubule dysfunction unless the subject is \< 6 months of age;
. Subject presents with another diagnosed condition as a potential etiology for her/his dRTA ;
. Subject requires therapy with potassium sparing diuretics, angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, trimethoprim, drospirenone and other progestins, nephrotoxic antibiotics, penicillins, tacrolimus, or medications known to delay gastric emptying or otherwise interfere with absorption of study product;
. Subject has evidence of obstructive uropathy or other findings on renal ultrasound expected to require intervention during the course of the study;
. Subject has any of the following laboratory abnormalities: