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Enteric Hyperoxaluria clinical trials

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NCT ID: NCT05650112 Recruiting - Healthy Clinical Trials

Safety and Tolerability of FB-001 in Healthy Adult Volunteers and Adult Subjects With Enteric Hyperoxaluria

Start date: November 16, 2022
Phase: Phase 1
Study type: Interventional

This Phase 1, first-in-human, randomized, double-blinded, placebo controlled study is evaluating FB-001 in healthy volunteers (Part 1) and participants diagnosed with enteric hyperoxaluria (Part 2). Eligible participants receive investigational product and undergo safety monitoring, evaluations and subsequent follow-up after investigational product administration.

NCT ID: NCT05377112 Completed - Clinical trials for Enteric Hyperoxaluria

Safety, Tolerability, and Pharmacodynamics of SYNB8802v1 in Subjects With History of Gastric Bypass Surgery or Short-bowel Syndrome

Start date: March 29, 2022
Phase: Early Phase 1
Study type: Interventional

Study SYNB8802-CP-002 is designed to assess safety, tolerability, and oxalate lowering, in subjects with a history of gastric bypass surgery or short-bowel syndrome. In addition, this study will explore other PD effects relative to baseline as well as predictors of efficacy and tolerability.

NCT ID: NCT05124886 Recruiting - Clinical trials for Enteric Hyperoxaluria

Gut Kidney Axis in Enteric Hyperoxaluria

Start date: November 10, 2022
Phase: N/A
Study type: Interventional

40 subjects with a confirmed diagnosis of IBD or >6 months post-RYGB with a diagnosed USD event or kidney stone on imaging within the past three years and 40 healthy controls will be administered a high oxalate diet on Days 0-3 and Days 21-24 with a washout period on Days 4-7 and will be administered 250mg sodium oxalate on Days 8-20, via prepared spinach, from Weil Cornell Medicine's Clinical and Translational Science Center. Subjects will partake in four stool collections, four 24-h urine collections, two blood collections, and four sets of colonic permeability testing.

NCT ID: NCT04909723 Terminated - Healthy Volunteers Clinical Trials

Safety, Tolerability, and Pharmacodynamics of NOV-001 in Adult Subjects

Start date: June 2, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The first stage of this study is a prospective, adaptive, Phase 1, first-in-human, randomized, controlled study evaluating safety, tolerability, and pharmacodynamics of NOV-001 in adult healthy volunteers. The second stage of this study is a prospective, randomized, single-blinded, placebo-controlled study of safety, tolerability, and early efficacy in patients with enteric hyperoxaluria.

NCT ID: NCT04629170 Completed - Healthy Clinical Trials

Safety and Tolerability of SYNB8802 in Healthy Adult Volunteers and Adult Subjects With Enteric Hyperoxaluria

Start date: November 4, 2020
Phase: Phase 1
Study type: Interventional

This Phase 1a/b, first-in-human, multiple dose-escalation, randomized, double-blinded, placebo-controlled study is evaluating SYNB8802 in healthy volunteers (HV) and subjects diagnosed with enteric hyperoxaluria (EH). Eligible subjects receive investigational product (IP) and undergo safety monitoring, evaluations, and subsequent follow-up after IP administration. In Part 2, all evaluations and assessments throughout this study may be conducted either at the clinical site or by a home healthcare professional at an alternative location (e.g., EH patient's home, hotel).

NCT ID: NCT03847090 Terminated - Clinical trials for Enteric Hyperoxaluria

Establishing the Safety and Efficacy of Reloxaliase in Patients With Enteric Hyperoxaluria

URIROX-2
Start date: August 26, 2019
Phase: Phase 3
Study type: Interventional

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

NCT ID: NCT03456830 Completed - Clinical trials for Enteric Hyperoxaluria

Evaluate ALLN-177 in Patients With Enteric Hyperoxaluria

Start date: May 21, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the efficacy and safety of ALLN-177 in patients with enteric hyperoxaluria.

NCT ID: NCT03391804 Completed - Clinical trials for Primary Hyperoxaluria

Study of ALLN-177 in Patients Aged 12 Years or Older With Enteric or Primary Hyperoxaluria and Hyperoxalemia

Start date: July 17, 2018
Phase: Phase 2
Study type: Interventional

Evaluate the efficacy and safety of ALLN-177 in reducing plasma and urinary oxalate levels in adult and pediatric patients with enteric hyperoxaluria and hyperoxalemia or primary hyperoxaluria

NCT ID: NCT00588120 Completed - Hyperoxaluria Clinical Trials

Enteric Oxalate Absorption Study in Unclassified Hyperoxaluria

Start date: December 1998
Phase: Phase 1
Study type: Interventional

The purpose of this study is to learn more about a condition called 'unclassified hyperoxaluria'. People with this condition have large amounts of oxalate in their urine, which can cause kidney stones and kidney failure. We do not know what causes the high level of oxalate in the urine. In this study, we will evaluate absorption of a test dose of oxalate taken orally by measuring the amount of the test dose that is eliminated in the urine. We will compare the results of affected patients to healthy volunteers.