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ADV7103 for Distal Renal Tubular Acidosis
Study Summary
This trial tests a drug to prevent acidosis in kids and adults with dRTA, using a double-blind, placebo-controlled study.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have kidney issues that might need treatment during the study.I have trouble taking pills or conditions that affect how my body absorbs medication.I have been hospitalized or had surgery recently, or plan to have surgery soon.I have had cancer other than skin or cervical in the last 5 years.I am between 6 months and 65 years old.I have a condition like lupus that could cause my kidney acid balance issue.You or your parent/guardian have reported alcohol or drug abuse in the past year.You have certain abnormal test results before starting the study.You show signs of problems with the part of your kidneys called the proximal tubule, such as low phosphorus levels or unusual amounts of sugar or amino acids in your urine.I need medication to keep my bicarbonate levels normal.I am using effective birth control or practicing abstinence.I have had dRTA for over 4 months if under 12, or over a year if 12 and older.I need medications that might affect how the study drug works.I have received a solid organ or bone marrow transplant.I am not pregnant, breastfeeding, nor planning to become pregnant during the study.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Group 1: ADV7103
- Group 2: Placebo Comparator
- 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
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."
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."
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."
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."
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."
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."
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."
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."
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