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Phase 2/3 Oxabact Study

2014-08-27 03:17:06 | BioPortfolio

Summary

The purpose of this study is to determine if Oxalobacter formigenes is effective at lowering urinary oxalate levels in patients with primary hyperoxaluria.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Primary Hyperoxaluria

Intervention

Oxalobacter formigenes, Placebo

Location

Mayo Clinic (Department of Pediatric Nephrology)
Rochester
Minnesota
United States
55905

Status

Recruiting

Source

OxThera

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:06-0400

Clinical Trials [100 Associated Clinical Trials listed on BioPortfolio]

Study to Evaluate the Efficacy and Safety of OxabactTM on Reduction of Urinary Oxalate in Primary Hyperoxaluria Patients

The main purpose of this study is to determine if Oxalobacter formigenes is effective at lowering urinary oxalate levels in patients with primary hyperoxaluria.

A Study to Evaluate the Efficacy and Safety of Oxabact in Patients With Primary Hyperoxaluria

This study will evaluate the efficacy and safety of OC5 in patients with PH.

A Study of DCR-PH1 in Patients With Primary Hyperoxaluria Type 1 (PH1)

A phase 1 study of DCR-PH1 in patients with primary hyperoxaluria type 1 (PH1) to determine the safety, tolerability, pharmacokinetic (PK) and pharmacodynamics (PD) effects of DCR-PH1 admi...

Primary Hyperoxaluria Mutation Genotyping

This study will help us determine whether certain genetic mutations, more than others, are a cause of more severe disease in Primary Hyperoxaluria.

Renal Protective Effect of ACEI and ARB in Primary Hyperoxaluria

This study will test the effectiveness of two medications: ACEI (angiotensin converting enzyme inhibitor)and ARB (angiotensin receptor blocker) in reducing the renal injury induced by hype...

PubMed Articles [6771 Associated PubMed Articles listed on BioPortfolio]

Genotype-phenotype variability of retinal manifestation in primary hyperoxaluria type 1.

Primary hyperoxaluria type 1 (PH1) is a rare congenital metabolic disorder of the glyoxylate pathway, which manifests with nephrocalcinosis, urolithiasis, and end-stage renal failure (ESRD) as well as...

Type 1 primary hyperoxaluria: A case report and focus on bone impairment of systemic oxalosis.

Primary hyperoxaluria is a rare genetic disorder characterized by oxalate overproduction, leading to kidney failure due to nephrocalcinosis, and is eventually responsible for systemic oxalosis. Bone i...

Invited response to Recurrence of oxalate nephropathy after isolated kidney transplantation for primary hyperoxaluria type 2.

We read with interest the letter from Dr. Del Bello and colleagues regarding our recent case report of successful combined liver/kidney transplantation in a patient with primary hyperoxaluria type 2 (...

Primary hiperoxaluria diagnosed after kidney transplantation: report of 2 cases and literature review.

Primary hyperoxaluria (PH) is a very rare genetic disorder; it is characterized by total or partial deficiency of the enzymes related to the metabolism of glyoxylate, with an overproduction of calcium...

Liposomal Bupivacaine Use in Third Molar Impaction Surgery: INNOVATE Study.

The analgesic efficacy and safety of liposomal bupivacaine (LB) in third molar extraction was evaluated in this phase 3, double-blind, placebo-controlled study of subjects undergoing bilateral third m...

Medical and Biotech [MESH] Definitions

The sole species of the genus Oxalobacter consisting of straight or curved gram-negative rods with rounded ends. Cells are nonmotile, nonsporing, and use oxylates as the only source of CARBON and energy, with formate and CARBON DIOXIDE as end products. They are isolated from lake sediments and from the rumen or large bowel of humans and animals. (From Bergey's Manual of Determinative Bacteriology, 9th ed)

A genetic disorder characterized by excretion of large amounts of OXALATES in urine; NEPHROLITHIASIS; NEPHROCALCINOSIS; early onset of RENAL FAILURE; and often a generalized deposit of CALCIUM OXALATE. There are subtypes classified by the enzyme defects in glyoxylate metabolism.

Excretion of an excessive amount of OXALATES in the urine.

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.

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