SIKAMIC (SIklos on Kidney Function and AlbuMInuria Clinical Trial)

Korábbi kezelés

• Patients treated with hydroxycarbamide for any reason within the previous 6 months.
• Patients with a history of hypertension (systolic blood pressure ≥ 140 or diastolic blood pressure ≥ 90 mmHg) treated with antihypertensive agent belonging to pharmacological class of RAS inhibitor.
• Patients with a concomitant primary kidney disease.
• Patients requiring long-term treatment with drugs potentially nephrotoxic (see non-exhaustive list).
• Patients requiring ACE inhibitors or ARBs within the 3 months before inclusion regardless of the indication.
• Patients requiring long-term treatment with non-steroid anti-inflammatory drugs.
• Simultaneous participation in other clinical trials on an investigational medicinal product or previous participation within 30 days before inclusion.

Más betegség

• Patients who have symptoms suggestive of urinary tract infection or patients with gross haematuria.
• Patients with any systemic condition that could result in a glomerulopathy not related to SCD (e.g. diabetes mellitus, active hepatitis B or C infections, HIV infection, systemic lupus erythematosus, inflammatory arthropathies).
• Patients known to be infected with HIV.
• Unreliable patients including non-compliant patients, patients with known alcoholism or drug abuse or with a history of a serious psychiatric disorder as well as patients unwilling to give informed consent or to abide by the requirements of the protocol.
• Patients with chronic conditions that upon investigator judgment may lead to a limited life expectancy

Laborértékek

• Patient with a stage 3, 4 or 5 chronic kidney disease (eGFR \< 60 mL/min per 1.73 m2).
• Patients with eGFR ≥ 140 ml/min/1,73m² due to the lack of information regarding the magnitude, direction and significance of the trends in eGFR evolution that could be expected in this population

Egyéb

• Patients who had severe VOC requiring hospitalisation or ACS within the last 4 weeks preceding screening visit.
• Patients who have had chronic blood transfusion or transfusion in the last 3 months.
• Patients who have a treatment which can modify the kidney function (see non-exhaustive list) in the last 3 months.
• Female patients who are pregnant or lactating.
• Persons in detention by judicial or administrative decision.

• Signed and dated Informed Consent Form (ICF) by a legally competent patient.
• Patients above 18 years.
• Patients with HbSS or HbSβ0 SCD.
• Patients with a value of albuminuria, assessed by ACR, over 3 mg/mmol and inferior to 100 mg/mmol confirmed by 3 positive urine samples taken one day apart.
• Female patients of childbearing potential or postmenopausal female with last period \< 12 months before screening agreeing to use a highly effective form of contraception (oral, injected or implanted hormonal contraception, intrauterine device, diaphragm, condom) during the trial and for 3 months after hydroxycarbamide discontinuation.
• Male patients with partners of childbearing potential agreeing to use a highly effective contraception during the trial and for 3 months after hydroxycarbamide discontinuation. Men with pregnant or lactating women should be advised to use a barrier method of contraception (condom) to prevent the foetus or breastfed infant from exposure to hydroxycarbamide.
• Patients who are covered by insurance scheme according to local regulatory requierements.