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Hyperoxaluria, Primary clinical trials

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NCT ID: NCT04555486 Completed - Clinical trials for Primary Hyperoxaluria Type 3

Study to Evaluate Safety, Tolerability, PK and PD of DCR-PHXC in PH Type 3 Patients

PHYOX4
Start date: September 14, 2020
Phase: Phase 1
Study type: Interventional

The DCR-PHXC-104 study is designed to assess the safety, tolerability, and pharmacological parameters of a single dose of DCR-PHXC in Primary Hyperoxaluria Type 3 (PH3). Participants should have had at least one stone event within 12 months of screening and intact renal function.

NCT ID: NCT03847909 Completed - Kidney Diseases Clinical Trials

A Study to Evaluate DCR-PHXC in Children and Adults With Primary Hyperoxaluria Type 1 and Primary Hyperoxaluria Type 2

PHYOX2
Start date: October 28, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of DCR-PHXC in Children and Adults with Primary Hyperoxaluria Type 1 (PH1) and Primary Hyperoxaluria Type 2 (PH2)

NCT ID: NCT03819647 Completed - Clinical trials for Primary Hyperoxaluria

Evaluation of the Efficacy of Stiripentol (Diacomit) as Monotherapy for the Treatment of Primary Hyperoxaluria

Start date: May 21, 2019
Phase: Phase 2
Study type: Interventional

Evaluation of the efficacy of stiripentol (Diacomit) as monotherapy for the treatment of primary hyperoxaluria. Pilot clinical study, open, prospective and multicenter.

NCT ID: NCT03681184 Completed - Clinical trials for Primary Hyperoxaluria Type 1 (PH1)

A Study to Evaluate Lumasiran in Children and Adults With Primary Hyperoxaluria Type 1

ILLUMINATE-A
Start date: November 27, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of lumasiran in children and adults with primary hyperoxaluria type 1 (PH1).

NCT ID: NCT03392896 Completed - Clinical trials for Primary Hyperoxaluria

Study of DCR-PHXC-101 in Normal Healthy Volunteers and Patients With Primary Hyperoxaluria

Start date: December 6, 2017
Phase: Phase 1
Study type: Interventional

This is a double-blind, placebo-controlled, dose escalation trial of DCR-PHXC in Healthy Volunteers (HVs) and patients with Primary Hyperoxaluria (PH). Once safety has been established in HV, PH patients with a confirmed diagnosis of PH1 and PH2 will be enrolled across multiple dosing cohorts. The study design will allow enrollment of PH patient cohorts at a given dose level once safety has been demonstrated in HV at that dose level. The study will be conducted in two parts: Part A: Single ascending dose (SAD) in HV; Part B: SAD in patients with PH1 and PH2 (lagging Part A by 1 dose level cohort).

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: NCT03350451 Completed - Clinical trials for Primary Hyperoxaluria

An Extension Study of an Investigational Drug, Lumasiran (ALN-GO1), in Participants With Primary Hyperoxaluria Type 1

Start date: April 4, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the long-term safety and tolerability of lumasiran in participants with Primary Hyperoxaluria Type 1.

NCT ID: NCT03116685 Completed - Clinical trials for Primary Hyperoxaluria

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

Start date: January 9, 2018
Phase: Phase 3
Study type: Interventional

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

NCT ID: NCT03067142 Completed - Clinical trials for Primary Hyperoxaluria Type 1

Proteomics of Primary Hyperoxaluria Type 1

PH1
Start date: January 5, 2017
Phase:
Study type: Observational

The purpose of this study is to identify unique urine protein markers of Primary Hyperoxaluria type 1 (PH1) compared to healthy controls. Urine protein markers can be identified by "proteomic" analyses in which proteins are processed in a lab to break them down into smaller building blocks. Using analytical chemistry techniques and specialized equipment many proteins can be identified and measured. Most proteins are found in healthy living cells while subtle changes in these proteins or the presence of different markers reflect abnormal processes and patterns of disease. When identified in disease, protein biomarkers can help to determine if a disease responds to new types of therapies. In this study, changes in urine proteomic patterns over time, their association with change in estimated (calculated) kidney filtering function, and the relative risk for progression of PH1 will be determined. Additionally, as part of the study, the investigators will measure urinary proteins and peptides that are markers of kidney tissue protection (for healthy healing of the kidneys from ongoing damage from high urine oxalate levels, oxalate crystals and stones) to establish if and when these markers are prospectively decreased in PH1 urine. Longitudinal studies of urine "proteomics" may assist in identifying the mechanisms behind PH1-related progression of kidney failure and might contribute important information towards future identification and development of effective therapies to slow or prevent kidney failure in PH1.

NCT ID: NCT02830009 Completed - Clinical trials for Primary Hyperoxaluria Type 1

IDENTIFICATION OF A MULTI-ANALYTE PROFILE FOR PRIMARY HYPEROXALURIA AND COMPARISON WITH HEALTHY SIBLINGS AND IDIOPATHIC HYPERCALCIURIA

PH1
Start date: May 2013
Phase: N/A
Study type: Interventional

The aim of this study is to know the difference between protein profiles (multi-analyte profile) of PH1 patients, idiopathic hypercalciuria (IH) patients and PH1 patients 'siblings. Idiopathic hypercalciuria is a less severe kidney disease that PH1, which also leads to the formation of kidney stones. The aim is to identify patterns of discriminating markers associated with primary hyperoxaluria type 1 (PH1) that will significantly improve clinical diagnosis and prognosis.