Location: Cleveland, OH

Indication: Kidney Stones

Sponsor: Allena Pharmaceuticals, Inc.

PI: Lawrence Gervasi, MD

Phase: 3

Ages: 18+

Criteria:

• Has an underlying enteric disorder associated with malabsorption (e.g., malabsorptive Has an underlying enteric disorder associated with malabsorption with known or suspected history of hyperoxaluria (e.g., history of kidney stones or oxalate nephropathy)
•  Urinary oxalate ≥ 50 mg/24 hr
• Has at least 1 documented kidney stone within 2 years
• Must NOT have acute renal failure or estimated glomerular filtration rate (eGFR) < 30 mL/minute/1.73 m2
• Must NOT have a known genetic, congenital, or other cause of kidney stones
• Must NOT be unable or unwilling to discontinue Vitamin C supplementation >200mg daily
• Must be able to establish baseline kidney stone burden

Compensation: You may be compensated for your time and travel

About:

The purpose of this study is to determine the efficacy, durability and long-term safety of reloxaliase in patients with enteric hyperoxaluria.

Location:  Cleveland, OH

Indication: Overactive Bladder

Sponsor: Urovant Sciences, GmbH

PI:  Lawrence Gervasi, MD

Intervention/Treatment: 

Phase: 3

Ages: 45+

Criteria:

• Male
• Participant should have been on and agree to continue to stay on a stable dose of benign prostatic hyperplasia (BPH) treatment with either a) alpha blocker monotherapy or b) alpha blocker + 5 alpha reductase inhibitor
• Participant has an International Prostate Symptom Score total score of ≥ 8
• Having at least 2 average nocturia episodes per night based on 3-day Bladder Diary at baseline. Nocturia is defined as waking to pass urine during the main sleep period.
• Must NOT have a history of 24-hour urine volume greater than 3,000 mL
• Must NOT have lower urinary tract pathology that could, in the opinion of the investigator, be responsible for urgency, frequency, or incontinence
• Must NOT have a history of prostate surgery, including minimally invasive transurethral or transrectal procedures, procedural treatments for BPH within 6 months of Screening or has a planned prostate surgery
• Must NOT have a history of urinary retention requiring an intervention (e.g., catheterization) for any reason

Compensation: You may be compensated for your time and travel

About: This study will assess the efficacy of vibegron compared with placebo in men with overactive bladder (OAB) symptoms on pharmacological therapy for benign prostatic hyperplasia (BPH) as defined by micturition and urgency episodes.

Location:  Cleveland, OH

Indication: Overactive Bladder

Sponsor: Urovant Sciences, GmbH

PI:  Lawrence Gervasi, MD

Intervention/Treatment: Vibegron

Ages: 45+

Criteria:

• Participant has completed participation of the 24-week double-blind treatment period in Study URO-901-3005 (NCT03902080) and demonstrated compliance with the study procedures and study medication schedule in the opinion of the investigator.
•  Participant has the ability to continue to receive a stable dose of Benign Prostatic Hyperplasia (BPH) treatment with either a) alpha blocker monotherapy or b) alpha blocker +5-ARI.
• In the opinion of the investigator, the participant is able and willing to comply with the requirements of the protocol, including completing study questionnaires and the Bladder Diary.
• Participant must NOT have experienced any Serious Adverse Event in Study URO-901-3005 that was reported as “possibly or probably related” to study treatment by the investigator.
• Participant must NOT be using any prohibited medications

Compensation: You may be compensated for your time and travel

About: This study will assess the long-term safety of vibegron when dosed up to 52 weeks in men with overactive bladder (OAB) symptoms on pharmacological therapy for Benign Prostatic Hyperplasia (BPH) who previously completed treatment in Study URO-901-3005 (NCT03902080).