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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05211037

Registration number

NCT05211037

Ethics application status

Date submitted

6/01/2022

Date registered

27/01/2022

Titles & IDs

Public title

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

Scientific title

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

Secondary ID [1]

21-AOI-09

Universal Trial Number (UTN)

Trial acronym

NEPHRO-DREPA

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Anemia

Sickle Cell Disease

Condition category

Condition code

Blood

Anaemia

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Diagnosis / Prognosis - Kidney function assessment

Experimental: Kidney function assessment -

Diagnosis / Prognosis: Kidney function assessment
kidney clearance measured by scintigraphy

Intervention code [1]

Diagnosis / Prognosis

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

renal clearance

Timepoint [1]

at baseline

Eligibility

Key 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

Minimum age

1 Year

Maximum age

21 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

* Pregnant patients (positive urine pregnancy test)
* Patients with other chronic conditions
* Progressive cancer or kidney disease
* Patients who are breastfeeding

Study design

Purpose of the study

Diagnosis

Allocation to intervention

Not applicable

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Phase

Not applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

15/11/2022

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

1/11/2024

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment outside Australia

Country [1]

France

State/province [1]

Nice

Funding & Sponsors

Primary sponsor type

Other

Name

Centre Hospitalier Universitaire de Nice

Address

Country

Ethics approval

Ethics application status

Summary

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.

Trial website

https://clinicaltrials.gov/study/NCT05211037

Trial related presentations / publications

Public notes

 This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts

Principal investigator

Name

Camille FAUDEUX, Dr

Address

Centre Hospitalier Universitaire de Nice

Country

Phone

Fax

Contact person for public queries

Name

Camille FAUDEUX, Dr

Address

Country

Phone

4.92.03.63.65

Fax

faudeux.c@chu-nice.fr

Contact person for scientific queries

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05211037

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Did you know?

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05211037