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

Polycystic Kidney Diseases Clinical Trial

— COMPLIK  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06036992
• Other study ID #: 29BRC22.0232 - COMPLIK
• Status: Not yet recruiting
• Start date: October 1, 2023
• Est. completion date: August 1, 2027

Study information

• Verified date: February 2023
• Source: University Hospital, Brest
• Contact: Yannick LE MEUR
• Phone: 02 98 34 70 74
• Email: yannick.lemeur[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: August 1, 2027
• Est. primary completion date: August 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Kidney Diseases
• Polycystic Kidney Diseases
• Polycystic Kidney, Autosomal Dominant

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Creation of a specific multidisciplinary consultation meeting	Meetings and exchanges between different health professionals: interventional radiologists, surgeons, infectiologists, hepatologists, pain specialists and nephrologists to discuss the best possible management for patients with complex cystic complications.	12 months
Secondary	Creation of an image bank	consulting images to recalculate and improve diagnostic scores	12 months
Secondary	Creation of a group of control patients	the change from baseline in quality of life scores at 1 year.	12 months