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Alkalinizing Agent

ADV7103 for Distal Renal Tubular Acidosis

Phase 3
Waitlist Available
Led By Laurence Greenbaum, MD, Ph.D.
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 ≥ 6 months of age and ≤ 65 years of age at time of consent
Subject requires ≥ 0.9 mEq/kg/day of alkali therapy to maintain serum bicarbonate levels above the LLN for the laboratory providing results
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 days
Awards & highlights

Study Summary

This trial tests a drug to prevent acidosis in kids and adults with dRTA, using a double-blind, placebo-controlled study.

Who is the study for?
This trial is for children and adults aged 6 months to 65 years with primary Distal Renal Tubular Acidosis (dRTA). Participants need a history of dRTA, require daily alkali therapy, and must use reliable birth control if applicable. Exclusions include organ transplant recipients, certain lab abnormalities, recent or upcoming surgeries, allergies to study drug ingredients, substance abuse within the last year, malignancy in the past five years except some skin/cervical cancers.Check my eligibility
What is being tested?
The study tests ADV7103 against a placebo in preventing metabolic acidosis as shown by serum bicarbonate levels. It's phase 3, prospective (forward-looking), multicenter (across multiple centers), randomized (participants are randomly assigned), double-blinded (neither participants nor researchers know who gets what treatment), and placebo-controlled.See study design
What are the potential side effects?
While specific side effects aren't listed here for ADV7103 or the placebo used in this trial for dRTA patients; generally speaking, potential side effects could range from digestive issues to allergic reactions depending on individual patient responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 6 months and 65 years old.
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I need medication to keep my bicarbonate levels normal.
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I am using effective birth control or practicing abstinence.
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I have had dRTA for over 4 months if under 12, or over a year if 12 and older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean change in blood bicarbonate levels

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: ADV7103Active Control1 Intervention
Patients continue to receive ADV7103 twice a day at their open label dose over 6 days
Group II: Placebo ComparatorPlacebo Group1 Intervention
Patients receive matched placebo twice a day until they reach a bicarbonate level of 18mEq/L

Find a Location

Who is running the clinical trial?

Advicenne PharmaLead Sponsor
4 Previous Clinical Trials
76 Total Patients Enrolled
Laurence Greenbaum, MD, Ph.D.Principal InvestigatorEmory University
Andre Ulmann, MD, Ph.D.Study ChairAdvicenne Pharma

Media Library

ADV7103 (Alkalinizing Agent) Clinical Trial Eligibility Overview. Trial Name: NCT03644706 — Phase 3
Distal Renal Tubular Acidosis Clinical Trial 2023: ADV7103 Highlights & Side Effects. Trial Name: NCT03644706 — Phase 3
Distal Renal Tubular Acidosis Research Study Groups: ADV7103, Placebo Comparator
ADV7103 (Alkalinizing Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03644706 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical investigation admit participants who are of legal age?

"As per the requirements of this trial, only people aged between 6 months and 65 years old are eligible to participate."

Answered by AI

What types of treatments does ADV7103 typically facilitate?

"ADV7103 is primarily employed to alleviate heartburn, but research suggests that it could also be beneficial for bowel preparation therapy, reducing gout flares and preventing nephrolithiasis or calcium oxalate."

Answered by AI

Is this medical experiment currently recruiting participants?

"Data hosted on clinicaltrials.gov suggest that this research project is not recruiting patients at the present moment, as it was most recently updated on May 8th 2023. However, there are 27 other studies actively seeking enrollees currently."

Answered by AI

Am I qualified to join this experiment?

"The requirements to join this medical trial are having distal renal tubular acidosis and being within the age range of 6 Months to 65 years old. This experiment is seeking approximately 40 participants."

Answered by AI

What other experiments have been conducted on ADV7103?

"Currently, 6 trials for ADV7103 are ongoing. Of these studies, 2 have reached Phase 3 status. Indianapolis is the primary testing ground for this medication, though 24 sites throughout the nation are running related clinical tests."

Answered by AI

Are there any known risks associated with the use of ADV7103?

"Our organisation has assigned ADV7103 a safety rating of 3, denoting that there is both supportive evidence for efficacy and repeated findings confirming its security."

Answered by AI

Are there any establishments in this state that are currently carrying out the clinical trial?

"Patents for this trial are being accepted at The Children's Hospital of Philadelphia in Pennsylvania, St. Louis Children's Hospital in Missouri and the Hospital for Sick Childern based out of Toronto, Ontario alongside 13 other medical sites."

Answered by AI

What is the capacity of this investigation in terms of participants?

"At present, there are no vacancies available on this clinical trial. Originally posted in September 1st 2023 and last updated in May 8th 2023, it is not currently enrolling patients. If you wish to explore other studies related to distal renal tubular acidosis or ADV7103, 21 and 6 trials respectively are actively seeking volunteers for their respective experiments."

Answered by AI
~2 spots leftby Mar 2025