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GRNA-001

Clinical trials are investigating GRNA-001 in people with Primary Hyperoxaluria Type 1 (PH1). The study is looking at safety and tolerability, and it is in an early phase trial with 23 participants. This article explains what the trial is studying and who it is for.

Table of Contents

Trial overview

The available clinical trial for GRNA-001 is NCT06839235, a Phase 1/2 interventional study in Primary Hyperoxaluria Type 1 (PH1).[1] The study status is Authorised, and the planned enrollment is 23 participants.[1]

Condition and population studied

This trial is focused on people with Primary Hyperoxaluria Type 1 (PH1), which is the only condition listed in the source data.[1] The data provided do not list more detailed inclusion or exclusion rules, so the main target population we can confirm is participants with PH1.[1]

Trial phase and design

The study is a Phase 1/2 trial, which means it is in an early stage of clinical research.[1] Phase 1 studies mainly look at safety, while Phase 2 studies begin to gather more information about how the treatment may perform in the disease being studied.[1]

The trial is described as interventional, meaning the researchers give the study treatment to participants and then measure the results.[1] The intervention listed is GRNA-001, and the trial title identifies the study as a Phase 1/2 study in PH1.[1]

Outcomes being measured

The main outcome is the incidence and severity of treatment-emergent adverse events (TEAEs), including TEAEs related to GRNA-001 and serious adverse events (SAEs).[1] In simple terms, researchers are counting health problems that start after treatment begins and checking how serious they are.[1]

This focus shows that the study is designed first to understand safety and tolerability, which is typical for an early phase trial.[1] The brief summary also states that the purpose is to evaluate the safety and tolerability of GRNA-001 in participants with PH1.[1]

What this means for patients

For patients, this trial means researchers are still learning how GRNA-001 behaves in people with PH1 and whether it can be used safely in this group.[1] Because the study is small, with 23 planned participants, it is meant to collect early research information rather than give final answers about treatment benefit.[1]

The source data do not provide details about visits, length of follow-up, or exact eligibility criteria, so those points cannot be confirmed from the trial record provided.[1] Based on the available information, the key topic is safety testing of GRNA-001 in a specific rare kidney-related condition, PH1.[1]

Trial IDPhaseCondition studiedStatusEnrollment
NCT06839235Phase 1/2Primary Hyperoxaluria Type 1 (PH1)Authorised23

FAQ

  • What is being studied in the GRNA-001 clinical trial? The trial is studying GRNA-001 in people with Primary Hyperoxaluria Type 1 (PH1). It is focused on safety and tolerability, which means how well people can receive the treatment and what side effects may happen.
  • Who can take part in the GRNA-001 trial? The trial is for participants with Primary Hyperoxaluria Type 1. The study data do not list more detailed eligibility rules here.
  • What phase is the GRNA-001 trial? This is a Phase 1/2 trial. Early phase studies usually look first at safety, then may also begin to look at early signs of benefit.
  • What outcomes are measured in the trial? The main outcome is the number and severity of treatment-emergent adverse events, also called TEAEs. The study also looks at serious adverse events, or SAEs.
  • How many people are in the GRNA-001 study? The trial plans to include 23 participants. This is a small study, which is common in early phase clinical research.

Ongoing Clinical Trials on GRNA-001

  • Study on the Safety and Effects of ABO-101 with mRNA-002 and gRNA-001 for Patients with Primary Hyperoxaluria Type 1

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    France Germany The Netherlands

Glossary

  • Primary Hyperoxaluria Type 1 (PH1): A rare inherited condition that causes the body to make too much oxalate, which can lead to kidney problems.
  • Phase 1/2: An early stage of clinical research. Phase 1 focuses mainly on safety, and Phase 2 begins to look more closely at how well the treatment may work.
  • Interventional study: A study where participants receive a treatment or procedure so researchers can measure its effects.
  • Enrollment: The number of people planned to join a study.
  • Safety: How well a treatment can be used without causing unacceptable harm.
  • Tolerability: How well people are able to take a treatment, including whether they can continue it.
  • Treatment-emergent adverse events (TEAEs): Health problems that start or get worse after the treatment begins.
  • Serious adverse events (SAEs): Severe health problems that may require hospital care, cause lasting harm, or be life-threatening.
  • Participants: People who join a clinical trial.

References