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Thyroid hormones may hold clues to kidney disease progression

NCT ID NCT07663773

Knowledge-focused Sponsor: Mario Negri Institute for Pharmacological Research Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This observational study will measure thyroid hormone levels in stored blood and urine samples from 51 people with severe chronic kidney disease (stages 4 and 5). Researchers aim to understand how these hormones differ in patients with and without polycystic kidney disease. The study does not involve any new treatment or intervention.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could reveal how thyroid hormones relate to kidney disease severity, potentially guiding future treatments.
What could go wrong
This is an observational study using stored samples, so it cannot prove cause and effect. Results may not apply to all kidney disease patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 51 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

1. Non-ADPKD CKD group Patients with severe chronic kidney disease (CKD stages G4-G5, not on dialysis) previously enrolled in the ADAPT clinical study (NCT04794517) conducted at the Clinical Research Center for Rare Diseases "Aldo e Cele Daccò", Istituto di Ricerche Farmacologiche Mario Negri IRCCS will be included. Only patients who provided informed consent for storage and future research use of biological samples and associated clinical data will be included. 2. ADPKD group A subset of patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) previously enrolled in the REORIENTED clinical study (NCT05646420), will be selected. These patients will be included only if they present the same CKD stage (G4-G5) as the non-ADPKD CKD group, in order to ensure comparability in terms of renal function impairment.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria * Non-ADPKD CKD * CKD stage G4, included in the ADAPT study * Availability of stored serum and urine samples in the biobank suitable for thyroid hormone analysis * Availability of relevant clinical and laboratory data within a predefined time window from sample collection * Signed informed consent for storage and future research use of biological samples and clinical data * ADPKD CKD * CKD stage G4, included in the REORIENTED study * Availability of complete thyroid hormone profile and relevant clinical data Exclusion criteria (applied to both groups as far as possible) * Known history of thyroid disease (hypothyroidism, hyperthyroidism, thyroiditis, or thyroid cancer) * Treatment with thyroid hormone replacement or antithyroid drugs * Use of medications known to interfere with thyroid function (e.g., amiodarone, lithium, interferon) * Systemic corticosteroid or immunosuppressive therapy at the time of sampling (if data available) * Dialysis treatment or history of kidney transplantation at the time of sampling * Acute illness, infection, or hospitalization close to the time of sample collection (if identifiable)

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Conditions

The condition(s) this trial relates to.

autosomal dominant polycystic kidney disease chronic kidney disease chronic renal failure syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic kidney disease (stages 4 and 5)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Clinical Research Centre for Rare Diseases Aldo e Cele Daccò

    Ranica, BG, 24020, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.