Screening for Renal Complications in Children & Young Adults With Major

Status Recruiting

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05211037
Study type	Interventional
Source	Centre Hospitalier Universitaire de Nice
Contact	Camille FAUDEUX, Dr
Phone	4.92.03.63.65
Email	faudeux.c@chu-nice.fr
Status	Recruiting
Phase	N/A
Start date	September 15, 2022
Completion date	September 2024

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT00801931` - Double Cord Blood Transplant for Patients With Malignant and Non-malignant Disorders	Phase 1/Phase 2
Completed	`NCT02948283` - Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia	Phase 1
Completed	`NCT03341338` - Genes-in-Action - Hepcidin Regulation of Iron Supplementation
Completed	`NCT00060398` - Epoetin Alfa With or Without Dexamethasone in Treating Fatigue and Anemia in Patients With Hormone-Refractory Prostate Cancer	Phase 3
Recruiting	`NCT05384691` - Efficacy of Luspatercept in ESA-naive LR-MDS Patients With or Without Ring Sideroblasts Who do Not Require Transfusions	Phase 2
Not yet recruiting	`NCT06038630` - 129Xe MRI Cardiopulmonary	Phase 2
Active, not recruiting	`NCT02101944` - Wild-Type Reovirus in Combination With Carfilzomib and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma	Phase 1
Not yet recruiting	`NCT05233956` - Levonorgestrel Intrauterine System Effects on Hemoglobin and Serum Ferritin Among Anemic Women in Kenya	N/A
Completed	`NCT02912533` - A Long-term Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD)	Phase 3
Completed	`NCT02888171` - Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency	N/A
Completed	`NCT03822884` - Pharmacokinetic/Pharmacodynamic Study of 3 Subcutaneous Single Dose Epoetin Alfa Formulations in Healthy Volunteers	Phase 1
Completed	`NCT02912494` - A Phase III Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD)	Phase 3
Completed	`NCT02930850` - Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation	N/A
Completed	`NCT02384122` - Efficacy of Octreotide on Blood and Iron Requirements in Patients With Anemia Due to Angiodysplasias	Phase 3
Completed	`NCT02603250` - Evaluation of Hemoglobin Measurement Tools for Child Anemia Screening in Rwanda	N/A
Completed	`NCT02176759` - Iron Absorption From Rice Fortified With Ferric Pyrophosphate	N/A
Completed	`NCT02310113` - Transfusion and Skeletal Muscle Tissue Oxygenation	N/A
Withdrawn	`NCT01934842` - A Study to Compare Analyte Levels in Blood Collected Using an Investigational Collection Device With a Commercial Predicate	N/A
Completed	`NCT01922479` - Pilot Study of Ferric Carboxymaltose to Treat Iron Deficiency in Asians With Heart Failure	Phase 4
Completed	`NCT01693029` - Study to Compare Safety and Efficacy of HX575 Epoetin Alfa and US-licensed Epoetin Alfa	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms