Acidosis, Renal TubularPhase 3NCT03831152
Extension Study in Primary Distal Renal Tubular Acidosis
A Phase 3 study testing ADV7103 in people with Acidosis, Renal Tubular, run by Advicenne Pharma at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 months to 65 years
- Conditions the study is for
- Acidosis, Renal Tubular
- What is being tested?
- ADV7103
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2023to Mar 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 months to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects who participated in Study B23CS must meet all of the following criteria to be registered into this study:
- 1. Female or male subjects who participated in Study B23CS and were adherent to the protocol;
- Subjects who did not participate in Study B23CS must meet all of the following criteria to be registered into this study:
- 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;
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- 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;
- 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;
- Subject or parent/guardian is willing and able to understand and sign informed consent and willing to comply with protocol instructions; child assent when appropriate; and
Who cannot join
- Subjects who participated in Study B23CS and meet any of the following criteria will be considered ineligible for registration into this study:
- 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.
- Subjects who did not participate in Study B23CS and meet any of the following criteria will be considered ineligible for registration into this study:
- 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;
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- 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:
- AST and/or ALT > 1.5x upper limit of normal (ULN)
- 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)
- Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 (according to the updated Schwartz formula for children and Chronic Kidney Disease - Epidemiology Collaboration [CKD-EPI] formula for adults)
- Total bilirubin > ULN, except with known Gilbert's disease.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Florida Pediatric Infectious Diseases
Tampa, Florida, 33606
About this study
Official title: A Phase 3B Open-Label Extension Of Study B23CS (ARENA 2) Evaluating The Continued Safety And Efficacy Of ADV7103 In Subjects With Primary Distal Renal Tubular Acidosis
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:
- subjects who participated in Study B23CS and were adherent to the protocol;
- subjects ≥ 6 months of age who are living in Europe and did not participate in Study B23CS; and
- infants younger than 6 months of age
- Conditions
- Acidosis, Renal Tubular
- Being tested
- ADV7103
- Medical subject headings
- Acidosis, Renal Tubular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADV7103Drug
Single group assignment
| Study group | Role | What they receive |
|---|---|---|
| Experimental ADV7103 | Experimental | All patients receive ADV7103 at their individualized dose Receives: Drug: ADV7103 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Safety of ADV7103 will be assessed by evaluating the frequency of Treatment-Emergent Adverse events as compared to placebo
Number/proportion of subjects presenting with ADV7103 treatment-related adverse events (AEs) during the study, by severity grade.
Measured: To 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start20 Dec 2023
- Primary completionJan 2025 (estimated)
- Study completionMar 2025 (estimated)
Why it stopped: No patients enrolled. Study no longer required due to completion of long term safety study in the EU.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acidosis, Renal TubularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advicenne Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andre Ulmann, M.D., Ph.D., Study chair, Advicenne Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03831152
- Sponsor's protocol ID
- B24CS
- Status last verified
- Feb 2026
- First submitted
- 23 Jan 2019
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3B Open-Label Extension Of Study B23CS (ARENA 2) Evaluating The Continued Safety And Efficacy Of ADV7103 In Subjects With Primary Distal Renal Tubular Acidosis
- ClinicalTrials.gov ID
- NCT03831152
- Acronym / sponsor ID
- B24CS
- Conditions
- Acidosis, Renal Tubular
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients enrolled. Study no longer required due to completion of long term safety study in the EU.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Advicenne PharmaIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 5 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- subjects who participated in Study B23CS and were adherent to the protocol;
- subjects ≥ 6 months of age who are living in Europe and did not participate in Study B23CS; and
- infants younger than 6 months of age
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental ADV7103 | Experimental | Drug: ADV7103All patients receive ADV7103 at their individualized dose |
Who may qualify
- Ages
- 4 months to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Subjects who participated in Study B23CS must meet all of the following criteria to be registered into this study:
- 1. Female or male subjects who participated in Study B23CS and were adherent to the protocol;
- Subjects who did not participate in Study B23CS must meet all of the following criteria to be registered into this study:
- Female or male subjects ≤ 65 years of age at time of consent with the following stipulations:
- Subjects < 6 months of age must be able to swallow (not suck) solid food without difficulty;
Key exclusion criteria (15 listed)
- Subjects who participated in Study B23CS and meet any of the following criteria will be considered ineligible for registration into this study:
- 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.
- Subjects who did not participate in Study B23CS and meet any of the following criteria will be considered ineligible for registration into this study:
- Female subject who is pregnant or lactating or has plans for pregnancy during the study;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADV7103Single group assignment | Drug | Experimental ADV7103 |
Primary outcome
The Safety of ADV7103 will be assessed by evaluating the frequency of Treatment-Emergent Adverse events as compared to placebo
Time frame: To 30 months
Number/proportion of subjects presenting with ADV7103 treatment-related adverse events (AEs) during the study, by severity grade.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Acidosis, Renal Tubular
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andre Ulmann, M.D., Ph.D. study chair
Advicenne Pharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ADV7103 in people with Acidosis, Renal Tubular, run by Advicenne Pharma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Safety of ADV7103 will be assessed by evaluating the frequency of Treatment-Emergent Adverse events as compared to placebo (time frame: To 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.