What you should know
ARENA2 is a pivotal Phase III, prospective, multicenter, randomized, double-blind, placebo-controlled clinical study that is expected to include approximately 40 patients in the United States and Canada. The principal objective of the clinical study is to evaluate the safety and efficacy of ADV7103 versus placebo in preventing the development of metabolic acidosis in patients with primary dRTA.
ARENA2 will be ready for patient entry in June 2021 and will employ a COVID-19 friendly protocol requiring no hospitalizations. ARENA2 was initiated following a European ARENA1 clinical trial that showed positive results with ADV7103 after 24 months of treatment. Talk to your doctor to see if clinical research may be right for you.
Introduction to the ARENA2 Study
ARENA2 is a 12-week, randomized withdrawal virtual study design, which allows entry to the study through an established virtual study platform. There are no requirements for hospital visits. Home visits by a specialized trained nurse can allow you to have the necessary tests in your home with a telemedicine appointment with your doctor. An Advicenne Patient Navigator can help put together an individualized plan for you that fits best with your schedule and provide support to you throughout the study.
Talk to your doctor if you are interested in participating in the ARENA2 trial or contact ARENA2info@advicenne.com. Voluntary participation in a clinical research trial is a personal decision and having all the information to make an informed decision is important. A discussion with your doctor can help you make an informed decision.
ADV7103 is an investigational oral medication designed to treat primary distal renal tubular acidosis (dRTA) in patients 6 months to 65 years of age. ADV7103 sachet (packets) contain tiny (2mm) granules of potassium bicarbonate and potassium citrate. The medication is designed to be taken twice a day and studies have shown that ADV7103 is tasteless and has less gastrointestinal side effects than current standard of care. Patients of all ages can take this medication and it may be put in yogurt or pudding for smaller children.
ADV7103 – Mechanism of Action
All total, the ARENA2 study is a 12-week clinical trial recruiting patients from the United States and Canada. Patients may also have the option of enrolling in the long-term extension study upon completion of the study. Period 3 of the ARENA2 is the most important part of the clinical study and requires that patients have their blood drawn once a day for up to 6 days to see how the medication is working. For patients receiving the placebo, not the study drug, this is especially important for monitoring your progress to see how your blood levels of potassium and bicarbonate are doing. If the lab levels are low, a home nurse will take another laboratory measurement to confirm the first result and your doctor will then advise on the next steps to complete the study and get you back on treatment.
The ARENA2 study is a virtual clinical study. Based on your specific needs, the ARENA2 trial can be conducted 100% virtually through telemedicine and qualified home-nursing services. There are no required overnight hospital stays and during the pandemic the virtual trial platform allows individuals to participate in the trial from the comfort of their home. To learn more about ARENA2, talk to your doctor. Some patients may choose to go to the clinic or doctor’s office for some of the study visits and all this will be individualized in a care plan specifically designed for you and your needs.
Talk to your doctor about the ARENA2 clinical study or visit www.clinicaltrials.gov to help locate participating centers. Alternatively, you can find out your enrollment options by sending an email to ARENA2info@Advicenne.com. As this is a virtual trial, there is the possibility of connecting with a site that is away from your home city and still be enrolled in the trial.
All study participants will be compensated for their time to complete daily journal entries and other study-related activities. There is no cost to participate in clinical research and all study medicine (e.g., ADV7103) for the ARENA2 study and the long-term extension is provided at no cost to participants.
Inclusion and exclusion criteria must be met before an individual can participate in the ARENA2 clinical trial.
- Female or male subjects ≥ 6 months of age and ≤ 65 years of age at time of consent
- Subject presents with a previous diagnosis of primary dRTA of at least 4 months duration for subjects < 12 years of age, and at least one year for those ≥ 12 years of age, based on documented history of non-anion gap, hyperchloremic, hypokalemic metabolic acidosis
- Subject requires ≥ 0.9 mEq/kg/day of alkali therapy to maintain serum bicarbonate levels above the lower limit of normal (LLN)
- Female subject who is pregnant or lactating or has plans for pregnancy during the study
- Subject has evidence of proximal tubule dysfunction (eg., hypophosphatemia, low serum uric acid, glycosuria, or amino aciduria)
- Subject presents with another diagnosed condition as a potential etiology for her/his dRTA (eg., systemic lupus erythematosus, Sjogren’s syndrome), in the opinion of the Investigator
- 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 associated with Visit 1 expected to require intervention during the study, in the opinion of the Investigator
- 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
- Subject has any of the following laboratory abnormalities associated with Visit 1:
- AST and/or ALT > 1.5x upper limit of normal (ULN)
- Serum potassium > 5.0 mEq/L or hypokalemia accompanied by clinical symptoms (e.g., 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
Do you have questions or want further information on the ARENA2 study? Send us a message and a member of our team will reach out!
dRTA Communities and Resources
Since its founding in 2007, Advicenne has been dedicated to developing and commercializing innovative treatments that address unmet medical needs in the area of nephrology. Our lead drug candidate, ADV7103, is in late-stage clinical trials for two indications: distal renal tubular acidosis (dRTA) and cystinuria. Listed on both the Euronext Paris and Euronext Brussels stock exchanges, the company is headquartered in Nîmes, France.
You are not alone. Connect with other members of the dRTA community on social media and with organizations providing education and support.