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Empagliflozin for Polycystic Kidney Disease
Study Summary
This trial will test if a drug called empagliflozin is safe and tolerable for people with a kidney disease called ADPKD. The trial will last 12 months and will involve 50 people.
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.Side effects data
From 2021 Phase 3 trial • 5988 Patients • NCT03057951Trial Design
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- Your blood pressure while sitting is less than 100 mm Hg.I am currently taking tolvaptan or a similar medication.I am currently taking medication to help remove excess fluid from my body.I have leg pain when walking, skin infections, or ulcers on my legs.Your blood pressure while sitting is higher than 160 mm Hg.I have been diagnosed with ADPKD according to specific criteria.I currently have a urinary tract or genital infection.My kidney function has been stable for the last 3 months.I have heart failure with a low heart pumping rate.You have been categorized as having a specific risk level based on imaging tests done at the Mayo Clinic.My kidney function, measured by eGFR, is between 30-90 ml/min/1.73m2.I am between 18 and 50 years old.I have been diagnosed with diabetes.Your blood sugar level when fasting is higher than 120 mg/dL.Your HbA1C level is 6.5% or higher.
- Group 1: Experimental
- 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
Is this trial open to those of a more advanced age?
"Only patients between the ages of 18 and 50 can join this clinical trial. For those under 18 years old, there are 45 other trials to consider; for individuals over 65, 447 options exist."
Is there an opportunity for me to take part in this experiment?
"50 individuals between 18 and 50 years old who possess Autosomal Dominant Polycystic kidney disease (ADPKD) according to modified Pei-Ravine Criteria, as well as a Mayo imaging risk classification of 1C, 1D or 1E with stable renal function in the preceding three months and eGFR values ranging from 30 - 90 ml/min/1.73m2 are being accepted into this trial."
What is the primary objective of this clinical experiment?
"During this 12 month investigation, the primary outcome of interest is to record patients' tolerability. Subsequently, we will also be tracking Height-Adjusted Total Kidney Volume with Magnetic Resonance Imaging scans at baseline, 3 months and 12 months; measuring mechanistic biomarkers such as plasma copeptin and urine KIM-1 levels; lastly assessing Patient Related Outcomes using the ADPKD Impact Scale (ADPKD-IS)."
Has the US Food & Drug Administration sanctioned Empagliflozin?
"Empagliflozin scored a 2 on the safety scale, indicating that while no efficacy data is available yet, there have been trials conducted to gauge its potential hazards."
Is recruitment still open for participants in this trial?
"According to data available on clinicaltrials.gov, this medical trial is not currently looking for participants. Initially posted on October 17th 2022 and last updated September 7th 2022, the study has no recruitment requirements at present. However, 488 other studies are actively searching for patients at the time of writing."
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