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NCT06036992Active, not recruiting

Study and Management of Cystic Complications in Autosomal Dominant Polycystic Kidney Disease

Source: ClinicalTrials.gov · Last updated 9 Aug 2024

Brief summary (registry, in English)

Autosomal dominant polycystic kidney disease is characterised by the development of renal and hepatic cysts. While the main complication is chronic end-stage renal failure, specific cyst-related complications are common: intracystic haemorrhage, renal or hepatic cyst infections, cyst-related mechanical complications and lithiasis. To date, there is no reliable epidemiological data on the frequency and clinical impact of these complications. Diagnosis of these complications is often complicated, and their management has not been codified. The latest international recommendations (KDIGO) provide only low-level recommendations. For the most complex cases (recurrent cystic infections, resistant pain, mechanical complications and malnutrition, need for pre-transplant nephrectomy, etc.), practitioners are often at a loss and management varies greatly from one centre to another.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
600 (estimated)
First submitted
26 Jun 2023
Start date
1 Oct 2023
Primary completion date
1 Aug 2027
Lead sponsor
University Hospital, Brest
NCT number
NCT06036992

What you commit to

  • Study type: Observational
  • Planned participants: 600
  • From 1 Oct 2023 to the primary completion date, 1 Aug 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Patients who have expressed their opposition to taking part in the study
  • Patient under legal protection (guardianship, curatorship, etc.)

Who the study is looking for

  • Patient with autosomal dominant polycystic kidney disease (APKD) participating in the Genkyst study
  • Patient with at least one cystic complication. The cystic complications retained are the following:
    • Acute or chronic cyst-related pain requiring analgesic treatments
    • Cyst infection
    • Intracystic haemorrhage
    • Urinary lithiasis
    • Functional complaints related to the cystic mass: digestive disorders with eating disorders, undernutrition, diaphragmatic compression phenomena, portal hypertension, umbilical or linea alba hernias, ventrations
    • Need for a cystic reduction procedure: puncture, marsupialization, open surgery (including preparation for grafting)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Chu Brest
Coordinator of this site? Confirm its status
BrestFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.