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Screening for Renal Complications in Children and Young Adults With Major Sickle Cell Disease (NEPHRO-DREPA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05211037
Recruitment Status : Not yet recruiting
First Posted : January 27, 2022
Last Update Posted : January 27, 2022
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Brief 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.

Condition or disease Intervention/treatment Phase
Anemia, Sickle Cell Diagnostic Test: Kidney function assessment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Screening for Renal Complications in Children and Young Adults With Major Sickle Cell Disease
Estimated Study Start Date : February 2022
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2024

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Kidney function assessment Diagnostic Test: Kidney function assessment
kidney clearance measured by scintigraphy

Primary Outcome Measures :
  1. renal clearance [ Time Frame: at baseline ]
    renal clearance measured by scintigraphy

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05211037

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Contact: Camille FAUDEUX, Dr ext +33 faudeux.c@chu-nice.fr

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CHU de Nice
Nice, France, 06001
Contact: Camille FAUDEUX, Dr ext +33    faudeux.c@chu-nice.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
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Principal Investigator: Camille FAUDEUX, Dr Centre Hospitalier Universitaire de Nice
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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT05211037    
Other Study ID Numbers: 21-AOI-09
First Posted: January 27, 2022    Key Record Dates
Last Update Posted: January 27, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Nice:
Sickle cell disease, renal complication
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hematologic Diseases
Genetic Diseases, Inborn