The purpose of this phase IIb, international, multicentre, double-blind, randomised, placebo-controlled study is to determine the effect of hydroxycarbamide on albuminuria after 6 months of treatment in SCD adult patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
86
Hydroxycarbamide tablets of 100 and 1000 mg
Placebo tablets of 100 and 1000 mg to mimic hydroxycarbamide tablets
Centre Suisse de Recherches Scientifiques en Côte d'Ivoire (CSRS)
Abidjan, Côte d’Ivoire
CHU d'Angers
Angers, France
Number of Patients Achieving at Least a 30% Decrease in ACR Baseline Value
The primary endpoint of this study is the proportion of patients in the hydroxycarbamide and placebo groups achieving at least a 30% decrease in ACR baseline value at 6 months after treatment initiation. Patients who do not achieve at least a 30% decrease of the ACR baseline value at month 6 will be considered non-responders.
Time frame: 6 months
Absolute Mean Changes in eGFR Value
Time frame: 6 months
Absolute Mean Changes in ACR Value
Time frame: 6 months
Proportion of Patients With a Shift From Macroalbuminuria to Microalbuminuria
Time frame: 6 months
Proportion of Patients With a Shift From Microalbuminuria to Normoalbuminuria
Time frame: 6 months
Proportion of Patients With a Shift From Macroalbuminuria to Normoalbuminuria
Time frame: 6 months
Proportion of Patients With a Shift From Microalbuminuria to Macroalbuminuria
Time frame: 6 months
Absolute Mean Changes of Systolic Blood Pressure
Time frame: 6 months
Absolute Mean Changes of Body Weight
Time frame: 6 months
Absolute Mean Changes of Diastolic Blood Pressure
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Hôpital Saint-André
Bordeaux, France
CHRU Brest
Brest, France
Hôpital Louis Mourier
Colombes, France
Pablo Bartolucci
Créteil, France
Hopital Edouard Herriot
Lyon, France
Hôpital de la Timone
Marseille, France
Hôpital européen Georges-Pompidou
Paris, France
Hôpital Saint-Antoine
Paris, France
...and 11 more locations
Time frame: 6 months
Absolute Mean Changes of Heart Rate Measure
Time frame: 6 months
Absolute Mean Changes in White Blood Cells Count
Time frame: 6 months
Absolute Mean Changes in Platelets Count
Time frame: 6 months
Absolute Mean Changes in Mean Corpuscular Volume
Time frame: 6 months
Absolute Mean Changes in Mean Corpuscular Haemoglobin Concentration
Time frame: 6 months
Absolute Mean Changes in Mean Corpuscular Haemoglobin
Time frame: 6 months
Absolute Mean Changes in Hemoglobin Count
Time frame: 6 months
Absolute Mean Changes in Foetal Hemoglobin Count
Time frame: 6 months
Absolute Mean Changes in Free Hemoglobin Count
Time frame: 6 months and 12 months for responder patients willing to continue the study after month 6.
Absolute Mean Changes in Dense Red Blood Cells Percentage
Time frame: 6 months and 12 months for responder patients willing to continue the study after month 6.
Absolute Mean Changes in Endogenous Erythropoietin Count
Time frame: 6 months
Absolute Mean Changes in Ferritin Count
Time frame: 6 months
Absolute Mean Changes in Lactate Dehydrogenase
Time frame: 6 months
Absolute Mean Changes in Aspartate Aminotransferase
Time frame: 6 months
Absolute Mean Changes in Alanine Amino Transferase
Time frame: 6 months
Absolute Mean Changes in Blood Urea Nitrogen
Time frame: 6 months
Absolute Mean Changes in Conjugated Bilirubin
Time frame: 6 months
Absolute Mean Changes in Total Bilirubin
Time frame: 6 months
Absolute Mean Changes in Reticulocytes
Time frame: 6 months