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SIKAMIC (SIklos on Kidney Function and AlbuMInuria Clinical Trial) (SIKAMIC)

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: NCT03806452
Recruitment Status : Recruiting
First Posted : January 16, 2019
Last Update Posted : October 16, 2019
Sponsor:
Information provided by (Responsible Party):
ADDMEDICA SASA

Brief Summary:
The purpose of this phase IIb, national (France), multicentre, double-blind, randomised, placebo-controlled study is to determine the effect of hydroxycarbamide on albuminuria after 12 months of treatment in SCD adult patients.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Drug: Hydroxycarbamide Drug: Placebo Oral Tablet Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Multicentre Randomized Double-blind Placebo-controlled Study to Evaluate the Effect on Albuminuria of 12 Months Treatment With Hydroxycarbamide (Siklos®) or a Placebo in Adults With Sickle Cell Disease:
Actual Study Start Date : May 28, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hydroxycarbamide

Hydroxycarbamide will be supplied as 100 mg or 1000 mg film-coated tablets. The posology will be based on the patient's body weight (bw). Hydroxycarbamide will be prescribed at a dose of 15 mg/kg bw/day and will be adminitered for 12 months.

In case of toxicity or innefficacy the dosage may be changed.

Drug: Hydroxycarbamide
Hydroxycarbamide tablets of 100 and 1000 mg
Other Name: Siklos

Placebo Comparator: Placebo

Placebo will be supplied as 100 mg or 1000 mg film-coated tablets. The posology will be based on the patient's body weight (bw). Placebo will be prescribed at a dose of 15 mg/kg bw/day and will be adminitered for 12 months.

In case of toxicity or innefficacy the dosage may be changed.

Drug: Placebo Oral Tablet
Placebo tablets of 100 and 1000 mg to mimic hydroxycarbamide tablets




Primary Outcome Measures :
  1. Proportion of patients achieving at least a 30% decrease in ACR baseline value [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Absolute mean changes in eGFR value [ Time Frame: 6 and 12 months ]
  2. Proportion of patients achieving at least a 30% decrease in ACR baseline value [ Time Frame: 6 months ]
  3. Absolute mean changes in ACR value [ Time Frame: 6 and 12 months ]
  4. Proportion of patients with a shift from macroalbuminuria to microalbuminuria [ Time Frame: 6 and 12 months ]
  5. Proportion of patients with a shift from microalbuminuria to normoalbuminuria [ Time Frame: 6 and 12 months ]
  6. Proportion of patients with a shift from macroalbuminuria to normoalbuminuria [ Time Frame: 6 and 12 months ]
  7. Proportion of patients with a shift from microalbuminuria to macroalbuminuria [ Time Frame: 6 and 12 months ]
  8. Evolution curve of ACR [ Time Frame: 6 and 12 months ]
  9. Evolution curve of eGFR [ Time Frame: 6 and 12 months ]
  10. Identification of clinical markers associated with response to treatment. [ Time Frame: 12 months ]
    Reported any sickle cell disease related organopathy

  11. Identification of biological markers associated with response to treatment. [ Time Frame: 12 months ]

    Haematology: Red blood cell count and Mean Corpuscular Volume, Dense Red Blood Cells, reticulocytes, Hemoglobin, free Hemoglobin and Fetal hemoglobin, Mean Corpuscular Hemoglobin and Mean Corpuscular Hemoglobin Concentration, hematocrit, White Blood Cell counts, neutrophils, lymphocytes, monocytes, eosinophils, basophils and platelet counts, endogenous EPO and ferritin concentrations.

    Blood biochemistry : Renal function: blood Creatinine. Haemolysis biochemical markers: Lactate Deshydrogenase, aspartate aminotransferase, ALT, BUN, conjugated and total bilirubin.


  12. Incidence of treatment-emergent AEs and SAEs [ Time Frame: Through study completion, an average of 1 year ]
  13. Absolute mean changes of systolic blood pressure [ Time Frame: 6 and 12 months ]
  14. Absolute mean changes of body mass index [ Time Frame: 6 and 12 months ]
  15. Absolute mean changes of diastolic blood pressure [ Time Frame: 6 and 12 months ]
  16. Absolute mean changes of heart rate measure [ Time Frame: 6 and 12 months ]
  17. Absolute mean changes in white blood cells count [ Time Frame: 6 and 12 months ]
  18. Absolute mean changes in platelets count [ Time Frame: 6 and 12 months ]
  19. Absolute mean changes in mean corpuscular volume [ Time Frame: 6 and 12 months ]
  20. Absolute mean changes in mean corpuscular haemoglobin concentration; [ Time Frame: 6 and 12 months ]
  21. Absolute mean changes in mean corpuscular haemoglobin [ Time Frame: 6 and 12 months ]
  22. Absolute mean changes in hemoglobin count [ Time Frame: 6 and 12 months ]
  23. Absolute mean changes in foetal hemoglobin count [ Time Frame: 6 and 12 months ]
  24. Absolute mean changes in free hemoglobin count [ Time Frame: 6 and 12 months ]
  25. Absolute mean changes in Dense red blood cells percentage [ Time Frame: 6 and 12 months ]
  26. Absolute mean changes in endogenous erythropoietin count [ Time Frame: 6 and 12 months ]
  27. Absolute mean changes in ferritin count [ Time Frame: 6 and 12 months ]
  28. Absolute mean changes in lactate dehydrogenase [ Time Frame: 6 and 12 months ]
  29. Absolute mean changes in Aspartate aminotransferase [ Time Frame: 6 and 12 months ]
  30. Absolute mean changes in Alanine Amino Transférase [ Time Frame: 6 and 12 months ]
  31. Absolute mean changes in blood urea nitrogen [ Time Frame: 6 and 12 months ]
  32. Absolute mean changes in conjugated bilirubin [ Time Frame: 6 and 12 months ]
  33. Absolute mean changes in total bilirubin [ Time Frame: 6 and 12 months ]
  34. Absolute mean changes in reticulocytes [ Time Frame: 6 and 12 months ]
  35. Rate of SCD-related clinical events [ Time Frame: 6 and 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed and dated Informed Consent Form (ICF) by a legally competent patient.
  2. Patients above 18 years.
  3. Patients with HbSS or HbSβ0 SCD.
  4. 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.
  5. 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.
  6. 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.
  7. Patients who are registered with a French national health insurance scheme or are covered by such a scheme.

Exclusion Criteria:

  1. Patients who had severe VOC requiring hospitalisation or ACS within the last 4 weeks preceding screening visit.
  2. Patients treated with hydroxycarbamide for any reason within the previous 6 months.
  3. Patients who have had chronic blood transfusion or transfusion in the last 3 months.
  4. Patients without any semen cryopreservation except vasectomised patients.
  5. 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.
  6. Patients who have symptoms suggestive of urinary tract infection or patients with gross haematuria.
  7. Patients with a concomitant primary kidney disease.
  8. 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).
  9. Patient with a stage 3, 4 or 5 chronic kidney disease (eGFR < 60 mL/min per 1.73 m2).
  10. 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
  11. Patients requiring long-term treatment with drugs potentially nephrotoxic (see non-exhaustive list).
  12. Patients requiring ACE inhibitors or ARBs within the 3 months before inclusion regardless of the indication.
  13. Patients requiring long-term treatment with non-steroid anti-inflammatory drugs.
  14. Patients who have a treatment which can modify the kidney function (see non-exhaustive list) in the last 3 months.
  15. Patients known to be infected with HIV.
  16. Female patients who are pregnant or lactating.
  17. 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.
  18. Simultaneous participation in other clinical trials on an investigational medicinal product or previous participation within 30 days before inclusion.
  19. Persons in detention by judicial or administrative decision.
  20. Patients with chronic conditions that upon investigator judgment may lead to a limited life expectancy

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): NCT03806452


Contacts
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Contact: Corinne Duguet, MD +33 1 49 70 95 85 corinne.duguet@addmedica.com
Contact: Laura Thomas-bourgneuf + 33 1 49 70 95 83 laura.thomas-bourgneuf@addmedica.com

Locations
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France
Pablo Bartolucci Recruiting
Créteil, France, 94017
Contact: Pablo Bartolucci       pablo.bartolucci@aphp.fr   
Sponsors and Collaborators
ADDMEDICA SASA
Investigators
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Principal Investigator: Pablo Bartolucci, Pr Henri Mondor Hospital
Study Chair: Vincent Audard, Pr Henri Mondor Hospital

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Responsible Party: ADDMEDICA SASA
ClinicalTrials.gov Identifier: NCT03806452    
Other Study ID Numbers: SIK-FR-17-1
First Posted: January 16, 2019    Key Record Dates
Last Update Posted: October 16, 2019
Last Verified: October 2019
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 ADDMEDICA SASA:
albuminuria
hydroxycarbamide
Additional relevant MeSH terms:
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Albuminuria
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Proteinuria
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms