Screening for Renal Complications in Children and Young Adults With Major Sickle Cell Disease

Anemia Clinical Trial

— NEPHRO-DREPA  

Official title:

Screening for Renal Complications in Children and Young Adults With Major Sickle Cell Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05211037
• Other study ID #: 21-AOI-09
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2022
• Est. completion date: September 2024

Study information

• Verified date: July 2023
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Camille FAUDEUX, Dr
• Phone: 4.92.03.63.65
• Email: faudeux.c[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Sickle cell disease is the subject of targeted neonatal screening (carried out when one of the two parents is from an endemic country - sub-Saharan Africa, South-East Asia, Central America, the Caribbean) during the Guthrie test. Haemolysis, which results from the abnormality of the haemoglobin, and the vascular activation it causes, are responsible for multiple organ damage. Major sickle cell syndromes (MSC), by several mechanisms, are responsible for a wide range of renal damage, culminating in end-stage renal failure at an average age of 45 years and with an average survival of 3 years beyond ESRD.

The various renal disorders are : glomerular hyperfiltration and then glomerulosclerosis; tubular dysfunction, especially proximal and distal hyposthenuria (a factor in enuresis); papillary necrosis, renal infarction, episodes of acute renal failure during vaso-occlusive crises; dysregulation of the renin-angiotensin system with early arterial hypertension and, more rarely, extra-membranous glomerulonephritis. In the early stages of these conditions, simple paraclinical tests can identify them before the appearance of specific clinical signs.

In patients suffering from MDS, the HAS (High Authority of Health) recommends an annual check-up carried out in a Competence Centre. According to the HAS recommendations for annual surveillance, in addition to the search for other organic complications, for renal pathology, only microalbuminuria and renal ultrasound are recommended. However, as the literature shows, microalbuminuria and ultrasound only detect some of these renal disorders and at a very late stage. A large number of publications in adults and, to a lesser degree, in children, demonstrate the correlation between the frequency of acute complications of sickle cell disease (episodes of haemolysis, etc.) and the occurrence of kidney damage.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 21 Years

Eligibility

Inclusion Criteria:

• Patient over 1 year old followed up in the Competence Centre at the Nice University Hospital, treated for a major sickle cell disease during the annual check-up

Exclusion Criteria:

• Pregnant patients (positive urine pregnancy test)

• Patients with other chronic conditions

• Progressive cancer or kidney disease

• Patients who are breastfeeding

Related Conditions & MeSH terms

• Anemia
• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

Diagnostic Test:
• Kidney function assessment
kidney clearance measured by scintigraphy

Locations

Country	Name	City	State
France	CHU de Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	renal clearance	renal clearance measured by scintigraphy	at baseline