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

NCT06036992 | Active Not Recruiting

• 1 other identifier: 29BRC22.0232 - COMPLIK
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Polycystic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

• To improve knowledge of the epidemiology of cystic complications within the Genkyst network

  number of cases of cystic complications per year per complication

  12 months

Secondary Outcomes (3)

• Creation of a specific multidisciplinary consultation meeting

  12 months

• Creation of an image bank

  12 months

• Creation of a group of control patients

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with autosomal dominant polycystic kidney disease included in Genkyst who present at least one cystic complication.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

Chu Brest

Brest, 29609, France

Location

MeSH Terms

Conditions

Polycystic Kidney Diseases

Condition Hierarchy (Ancestors)

Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: September 14, 2023
• Study Start: October 1, 2023
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations

FR (1)