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

April 28, 2025 updated by: Theravia

Multicentre Randomized Double-blind Placebo-controlled Study to Evaluate the Effect on Albuminuria of 6 Months Treatment With Hydroxycarbamide (Siklos®) or a Placebo in Adults With Sickle Cell Disease:

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
86

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Côte D'Ivoire
      • Abidjan, Côte D'Ivoire
        • Centre Suisse de Recherches Scientifiques en Côte d'Ivoire (CSRS)
  • France
      • Angers, France
        • CHU d'Angers
      • Bordeaux, France
        • Hôpital Saint-André
      • Brest, France
        • CHRU Brest
      • Colombes, France
        • Hopital Louis Mourier
      • Créteil, France, 94017
        • Pablo Bartolucci
      • Lyon, France
        • Hopital Edouard Herriot
      • Marseille, France
        • Hôpital de la Timone
      • Paris, France
        • Hôpital Saint-Antoine
      • Paris, France
        • Hôpital Européen Georges-Pompidou
      • Paris, France
        • Service de biothérapie, consultation hématologie-drépanocytose hôpital Necker
      • Poitiers, France
        • Chu La Miletrie
      • Reims, France
        • Hopital Robert Debre Chu Reims
      • Rennes, France
        • Hôpital Pontchaillou
      • Rouen, France
        • CHU Charles Nicolle
      • Saint-Denis, France
        • Centre hospitalier Delafontaine
      • Toulouse, France
        • Institut Universitaire du Cancer de Toulouse - Oncopole
  • Guadeloupe
      • Pointe-à-Pitre, Guadeloupe
        • CHU Pointe-à-Pitre/Abymes
  • Mali
      • Bamako, Mali
        • Centre de Recherche et de Lutte contre la Drépanocytose de Bamako (CRLD)
  • Martinique
      • Le Lamentin, Martinique
        • CHU Martinique
  • Senegal
      • Dakar, Senegal
        • Service d'Hématologie Clinique, Centre National de Transfusion sanguine, Université Cheikh Anta Diop

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 covered by insurance scheme according to local regulatory requierements.

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 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.
  5. Patients who have symptoms suggestive of urinary tract infection or patients with gross haematuria.
  6. Patients with a concomitant primary kidney disease.
  7. 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).
  8. Patient with a stage 3, 4 or 5 chronic kidney disease (eGFR < 60 mL/min per 1.73 m2).
  9. 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
  10. Patients requiring long-term treatment with drugs potentially nephrotoxic (see non-exhaustive list).
  11. Patients requiring ACE inhibitors or ARBs within the 3 months before inclusion regardless of the indication.
  12. Patients requiring long-term treatment with non-steroid anti-inflammatory drugs.
  13. Patients who have a treatment which can modify the kidney function (see non-exhaustive list) in the last 3 months.
  14. Patients known to be infected with HIV.
  15. Female patients who are pregnant or lactating.
  16. 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.
  17. Simultaneous participation in other clinical trials on an investigational medicinal product or previous participation within 30 days before inclusion.
  18. Persons in detention by judicial or administrative decision.
  19. Patients with chronic conditions that upon investigator judgment may lead to a limited life expectancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 6 months.

Hydroxycarbamide will be administered for 12 months for patients qualified as responders willing to continue to participate in the trial.
Drug: Hydroxycarbamide
Hydroxycarbamide tablets of 100 and 1000 mg
Other Names:
  • 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 6 months.

Hydroxycarbamide will be administered for 12 months for patients qualified as responders willing to continue to participate in the trial.
Drug: Placebo Oral Tablet
Placebo tablets of 100 and 1000 mg to mimic hydroxycarbamide tablets

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Patients Achieving at Least a 30% Decrease in ACR Baseline Value
Time Frame: 6 months
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.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Absolute Mean Changes in eGFR Value
Time Frame: 6 months
6 months
Absolute Mean Changes in ACR Value
Time Frame: 6 months
6 months
Proportion of Patients With a Shift From Macroalbuminuria to Microalbuminuria
Time Frame: 6 months
6 months
Proportion of Patients With a Shift From Microalbuminuria to Normoalbuminuria
Time Frame: 6 months
6 months
Proportion of Patients With a Shift From Macroalbuminuria to Normoalbuminuria
Time Frame: 6 months
6 months
Proportion of Patients With a Shift From Microalbuminuria to Macroalbuminuria
Time Frame: 6 months
6 months
Absolute Mean Changes of Systolic Blood Pressure
Time Frame: 6 months
6 months
Absolute Mean Changes of Body Weight
Time Frame: 6 months
6 months
Absolute Mean Changes of Diastolic Blood Pressure
Time Frame: 6 months
6 months
Absolute Mean Changes of Heart Rate Measure
Time Frame: 6 months
6 months
Absolute Mean Changes in White Blood Cells Count
Time Frame: 6 months
6 months
Absolute Mean Changes in Platelets Count
Time Frame: 6 months
6 months
Absolute Mean Changes in Mean Corpuscular Volume
Time Frame: 6 months
6 months
Absolute Mean Changes in Mean Corpuscular Haemoglobin Concentration
Time Frame: 6 months
6 months
Absolute Mean Changes in Mean Corpuscular Haemoglobin
Time Frame: 6 months
6 months
Absolute Mean Changes in Hemoglobin Count
Time Frame: 6 months
6 months
Absolute Mean Changes in Foetal Hemoglobin Count
Time Frame: 6 months
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.
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.
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
6 months
Absolute Mean Changes in Ferritin Count
Time Frame: 6 months
6 months
Absolute Mean Changes in Lactate Dehydrogenase
Time Frame: 6 months
6 months
Absolute Mean Changes in Aspartate Aminotransferase
Time Frame: 6 months
6 months
Absolute Mean Changes in Alanine Amino Transferase
Time Frame: 6 months
6 months
Absolute Mean Changes in Blood Urea Nitrogen
Time Frame: 6 months
6 months
Absolute Mean Changes in Conjugated Bilirubin
Time Frame: 6 months
6 months
Absolute Mean Changes in Total Bilirubin
Time Frame: 6 months
6 months
Absolute Mean Changes in Reticulocytes
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Theravia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pablo Bartolucci, Pr, Henri Mondor University Hospital
  • Study Chair: Vincent Audard, Pr, Henri Mondor University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 28, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 9, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 16, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 14, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SIK-FR-17-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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