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Alkali Therapy
ADV7103 for Renal Tubular Acidosis
Phase 3
Waitlist Available
Research Sponsored by Advicenne Pharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female or male subjects ≤ 65 years of age at time of consent with specific residency requirements
Subject ≥ 6 months of age requires ≥ 0.9 mEq/kg/day of alkali therapy to maintain serum bicarbonate levels above the LLN
Timeline
Screening 3 weeks
Treatment Varies
Follow Up to 30 months
Awards & highlights
Study Summary
This trial tests a drug to prevent metabolic acidosis & hypokalemia in kids & adults with primary dRTA in Europe.
Who is the study for?
This trial is for people with primary distal Renal Tubular Acidosis (dRTA) in Europe, including those who were in a previous study and followed the rules. It's open to all ages up to 65 years old, but they must not be planning surgeries or pregnancies soon, and can't have other health issues that could affect their dRTA.Check my eligibility
What is being tested?
The trial tests ADV7103's long-term safety and effectiveness in managing serum bicarbonate levels, preventing metabolic acidosis, and avoiding low potassium levels in patients with primary dRTA. It includes subjects from a prior study as well as new participants.See study design
What are the potential side effects?
While specific side effects of ADV7103 are not listed here, common concerns may include digestive discomforts, potential allergic reactions to medication ingredients, or imbalances in electrolytes which will be monitored throughout the study.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 65 or younger and live in the required area.
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I need daily medication to keep my bicarbonate levels normal.
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I have been diagnosed with primary distal renal tubular acidosis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ to 30 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~to 30 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The Safety of ADV7103 will be assessed by evaluating the frequency of Treatment-Emergent Adverse events as compared to placebo
Trial Design
1Treatment groups
Experimental Treatment
Group I: Experimental ADV7103Experimental Treatment1 Intervention
All patients receive ADV7103 at their individualized dose
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Who is running the clinical trial?
Advicenne PharmaLead Sponsor
4 Previous Clinical Trials
79 Total Patients Enrolled
Andre Ulmann, M.D., Ph.D.Study ChairAdvicenne Pharma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 65 or younger and live in the required area.You have another diagnosed condition that could be causing your dRTA.I need daily medication to keep my bicarbonate levels normal.My urine is not too acidic and my blood has enough bicarbonate. I'm on alkali therapy and possibly potassium.I have a blockage in my urinary system that might need treatment.I have been hospitalized or had surgery recently, or plan to have surgery soon.I have been diagnosed with primary distal renal tubular acidosis.The participant has certain abnormal test results.I am not pregnant, breastfeeding, nor planning to become pregnant during the study.I need medications that might affect how a study drug works.I have kidney issues related to the proximal tubule, unless I am under 6 months old.You were part of another study called B23CS and followed its rules.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental ADV7103
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the eligibility criteria for this trial encompass individuals of all ages, or are there specific age restrictions?
"This clinical trial is gathering participants in the age range of 4 months to 65 years."
Answered by AI
What risks do participants face in undertaking research with ADV7103?
"Taking into consideration the data collected from prior trials, our team at Power rated ADV7103's safety as a 3. This is because Phase 3 clinical studies have indicated efficacy and evidence of its safety."
Answered by AI
Is this experiment currently seeking participants?
"According to the details found on clinicaltrials.gov, this trial is not presently enrolling participants. It was first posted in December 1st 2023 and last modified on May 8th 2023. Nevertheless, there are currently 22 other trials that welcome potential candidates."
Answered by AI
To what demographic is enrollment in this experiment open?
"The eligibility criteria for this trial require patients to have renal tubular acidosis and be between the ages of 4 months old and 65. In total, 40 participants are planned to take part in the study."
Answered by AI
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