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Anakinra vs Prednisone to Treat Gout Flare in Patients With Chronic Kidney Disease Stage 4/5 or Renal Transplantation (Ana4CKD)

Primary Purpose

Gout, Chronic Kidney Disease, Renal Transplantation

Status
Recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Anakinra 100Mg/0.67Ml Inj Syringe
Prednisone
Placebo of Prednisone
Placebo of Anakinra
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gout focused on measuring Gout, Flare, Urate crystals, Chronic kidney disease, Anakinra, IL-1b, Corticosteroid, Renal transplantation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults aged over 18 years old
  • Gout confirmed by identification of urate crystals by joint fluid or tophus analysis or by ultrasound of the affected joint and/or
  • Gout according to Nijmegen criteria (presence of a score ≥ 8/13) depending on the following items:

Man (2 pts) Previous crisis (2 pts) Involvement of first metatarsophalangeal joint (MTP1) (2.5 pts) Maximum pain within 24 hours (0.5pt) Redness (1 pt) HTA or cardiovascular disease (1.5 pts) SUL > 360 μmol/l during the crisis (3.5 pts)

  • Chronic kidney disease stage 4/5 or renal transplantation
  • Flare ≤ 5 days
  • Pain assessed by visual analogical scale > 4/10

Exclusion Criteria:

  • Participating in another trial including the administration of a drug
  • Active infection
  • History of anakinra or prednisone allergy
  • Contra-indication of anakinra or prednisone
  • Neutrophil count < 1000/mm3 (not due to ethnic cause)
  • Difficulty understanding French
  • Illiteracy
  • Pregnant women or breastfeeding mothers (see PHC article L.1121-5)
  • Persons deprived of liberty by judicial or administrative decision, persons receiving psychiatric care under Sections L. 3212-1 and L. 3213-1 and persons admitted to a health or social institution for purposes other than research (see CSP Article L.1121-6)
  • Major persons subject to a measure of legal protection or unseeding to express consent (see PHC Article L.1121-8)
  • Persons not affiliated to a social security plan or beneficiaries of such a plan (see PHC Article L.1121-8-1)

Sites / Locations

  • Rhumathology departmentRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Anakinra

Prednisone

Arm Description

Anakinra 100 mg/d+Placebo of Prednisone

Prednisone 30 mg/d+Placebo of Anakinra

Outcomes

Primary Outcome Measures

Pain difference between Day 3 and treatment initiation
Pain difference between day 3 and treatment initiation assessed by visual analogical scale (VAS) from 0 to 10 VAS = 0, no pain VAS =10, maximal pain

Secondary Outcome Measures

Percentage of responders (improvement ≥ 50%) at day 5
Percentage of responders (improvement ≥ 50%) at day 5
Percentage of flare resolution (improvement ≥ 80%) at day 5
Percentage of flare resolution (improvement ≥ 80%) at day 5
Time to treatment response
Time to treatment response
Time to flare resolution
Time to flare resolution
Treatment duration
Treatment duration
Duration of hospitalization
Duration of hospitalization
Healthcare consumption at month 1 : number of consultations and hospitalizations related to gout flare
Healthcare consumption at month 1 assessed by number of consultations and hospitalizations related to gout flare
Healthcare consumption at month 1: total hospital stay
Healthcare consumption at month 1 assessed by total hospital stay
Healthcare consumption at month 1
Healthcare consumption at month 1 assessed by number and cumulative duration of sick leave related to gout
Side effects
Side effects
Comorbidity decompensations at month 1 : DT2 decompensation
Comorbidity decompensations at month 1 assessed by DT2 decompensation measure
Comorbidity decompensations at month 1: Blood pressure
Comorbidity decompensations at month 1 assessed by Blood pressure measure
Comorbidity decompensations at month 1: Hypertension
Comorbidity decompensations at month 1 assessed by hypertension measure
Comorbidity decompensations at month 1: Weight
Comorbidity decompensations at month 1 assessed by Weight measure
Comorbidity decompensations at month 1: number of Cardiovascular events : coronary disease, heart attack, stroke
Comorbidity decompensations at month 1 assessed by number of Cardiovascular events : coronary disease, heart attack, stroke
Comorbidity decompensations at month 1: Blood analysis of serum creatinine level
Comorbidity decompensations at month 1 assessed by serum creatinine level measure
Comorbidity decompensations at month 1: Blood analysis of epidermal Growth Factor Receptor (eGFR)
Comorbidity decompensations at month 1 assessed by eGFR measure
Comorbidity decompensations at month 1: Blood analysis of C reactive protein (CRP)
Comorbidity decompensations at month 1 assessed by CRP measure
Comorbidity decompensations at month 1: Blood analysis of HbA1C
Comorbidity decompensations at month 1 assessed by HbA1C measure
Comorbidity decompensations at month 1: Blood analysis of total cholesterol
Comorbidity decompensations at month 1 assessed by total cholesterol measure
Comorbidity decompensations at month 1: Blood analysis of LDL cholesterol
Comorbidity decompensations at month 1 assessed by HDL cholesterol measure
Comorbidity decompensations at month 1: Blood analysis of HDL cholesterol
Comorbidity decompensations at month 1 assessed by HDL cholesterol measure
Comorbidity decompensations at month 1: Blood analysis of triglyceride
Comorbidity decompensations at month 1 assessed by triglyceride measure
Comorbidity decompensations at month 1: Blood analysis of glycaemia
Comorbidity decompensations at month 1 assessed by glycaemia measure
site injection reaction during day 0 to day 5: pain
site injection reaction during day 0 to day 5 assessed by pain (0-10 scale VAS) measure
site injection reaction during day 0 to day 5: inflammatory reaction
site injection reaction during day 0 to day 5 assessed by CRP level measure
site injection reaction during day 0 to day 5: swelling (yes/no)
site injection reaction during day 0 to day 5 assessed by swelling (yes/no)
site injection reaction during day 0 to day 5: itching (yes/no)
site injection reaction during day 0 to day 5 assessed by itching (yes/no)
site injection reaction during day 0 to day 5: redness (yes/no)
site injection reaction during day 0 to day 5 assessed by redness (yes/no)

Full Information

First Posted
January 24, 2021
Last Updated
August 22, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT04844814
Brief Title
Anakinra vs Prednisone to Treat Gout Flare in Patients With Chronic Kidney Disease Stage 4/5 or Renal Transplantation
Acronym
Ana4CKD
Official Title
Anakinra vs Prednisone to Treat Gout Flare in Patients With Chronic Kidney Disease Stage 4/5 or Renal Transplantation: a Randomized, Double Blinded, Multicenter Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 2, 2022 (Actual)
Primary Completion Date
June 2, 2025 (Anticipated)
Study Completion Date
July 2, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Gout is secondary to urate crystal deposition after chronic elevation of serum urate level. Urate crystal deposition is responsible for acute and recurrent inflammatory flares which can be treated with colchicine, non-steroid anti-inflammatory drugs (NSAID), corticosteroid or interleukin (IL)-1b blockade. Colchicine and NSAID are contra-indicated in patients with chronic renal disease (CKD) stage 4/5 or with renal transplantation. In these patients gout flare is treated with high dose of corticosteroid or IL-1b inhibitors. Frequent use of high dose of corticosteroid can worsen gout comorbidities including mellitus diabetes type 2, hypertension, obesity and dyslipidemia. Anakinra, an IL-1b receptor antagonist, is efficient in gout flare in patients without CKD stage 4/5. The aim of this study is to demonstrate that anakinra is superior to prednisone to treat gout flare in patients with CKD 4/5 or renal transplantation.
Detailed Description
The study will include 234 gouty patients with CKD 4/5 or renal transplantation with gout flare This study will include the following visits: - Selection/inclusion visit (V0): Patient with gout flare and CKD 4/5 or renal transplantation will be included and randomized to receive either anakinra 100 mg/d or prednisone 30 mg/d. -Visit from day (d)0 to d5: included patients will be hospitalized and treatment will be administrated by a nurse. Treatment will be stopped if patient had ≥ 80% improvement. Treatment response is defined by improvement ≥ 50%. Patient will be evaluated every day from d0 to d5. At d3, if improvement is < 50%, patient will be considered as non-responder and patient will be managed as physician's habits. At d5, if improvement is < 80%, patient will be managed as physician's habits Between d1 and d5, if improvement ≥ 80%, patient can be discharged and will have a visit at d5 as outpatient. - Visit month (M)1 end of research: clinical evaluation of gout, demographic characteristics, medication, number of gout flare within the month, number of hospitalization and/or medical consultation within the month, blood analysis (serum creatinine level, eGFR, SUL, CRP, HbA1C, total, HDL and LDL cholesterol, triglyceride, glycaemia). The study ends after the M1 consultation. The total duration of participation in the study is 1 month.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gout, Chronic Kidney Disease, Renal Transplantation
Keywords
Gout, Flare, Urate crystals, Chronic kidney disease, Anakinra, IL-1b, Corticosteroid, Renal transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
204 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anakinra
Arm Type
Experimental
Arm Description
Anakinra 100 mg/d+Placebo of Prednisone
Arm Title
Prednisone
Arm Type
Active Comparator
Arm Description
Prednisone 30 mg/d+Placebo of Anakinra
Intervention Type
Drug
Intervention Name(s)
Anakinra 100Mg/0.67Ml Inj Syringe
Intervention Description
Anakinra 100 mg/d subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
Prednisone 30 mg/d
Intervention Type
Drug
Intervention Name(s)
Placebo of Prednisone
Intervention Description
Placebo of Prednisone
Intervention Type
Drug
Intervention Name(s)
Placebo of Anakinra
Intervention Description
Placebo of Anakinra
Primary Outcome Measure Information:
Title
Pain difference between Day 3 and treatment initiation
Description
Pain difference between day 3 and treatment initiation assessed by visual analogical scale (VAS) from 0 to 10 VAS = 0, no pain VAS =10, maximal pain
Time Frame
Day 3
Secondary Outcome Measure Information:
Title
Percentage of responders (improvement ≥ 50%) at day 5
Description
Percentage of responders (improvement ≥ 50%) at day 5
Time Frame
Day 5
Title
Percentage of flare resolution (improvement ≥ 80%) at day 5
Description
Percentage of flare resolution (improvement ≥ 80%) at day 5
Time Frame
Day 5
Title
Time to treatment response
Description
Time to treatment response
Time Frame
Day 3 or Day 5
Title
Time to flare resolution
Description
Time to flare resolution
Time Frame
Day 3 or Day 5
Title
Treatment duration
Description
Treatment duration
Time Frame
Day3 or Day 5
Title
Duration of hospitalization
Description
Duration of hospitalization
Time Frame
Day 3 or Day 5
Title
Healthcare consumption at month 1 : number of consultations and hospitalizations related to gout flare
Description
Healthcare consumption at month 1 assessed by number of consultations and hospitalizations related to gout flare
Time Frame
Month 1
Title
Healthcare consumption at month 1: total hospital stay
Description
Healthcare consumption at month 1 assessed by total hospital stay
Time Frame
Month 1
Title
Healthcare consumption at month 1
Description
Healthcare consumption at month 1 assessed by number and cumulative duration of sick leave related to gout
Time Frame
Month 1
Title
Side effects
Description
Side effects
Time Frame
Month 1
Title
Comorbidity decompensations at month 1 : DT2 decompensation
Description
Comorbidity decompensations at month 1 assessed by DT2 decompensation measure
Time Frame
Month 1
Title
Comorbidity decompensations at month 1: Blood pressure
Description
Comorbidity decompensations at month 1 assessed by Blood pressure measure
Time Frame
Month 1
Title
Comorbidity decompensations at month 1: Hypertension
Description
Comorbidity decompensations at month 1 assessed by hypertension measure
Time Frame
Month 1
Title
Comorbidity decompensations at month 1: Weight
Description
Comorbidity decompensations at month 1 assessed by Weight measure
Time Frame
Month 1
Title
Comorbidity decompensations at month 1: number of Cardiovascular events : coronary disease, heart attack, stroke
Description
Comorbidity decompensations at month 1 assessed by number of Cardiovascular events : coronary disease, heart attack, stroke
Time Frame
Month 1
Title
Comorbidity decompensations at month 1: Blood analysis of serum creatinine level
Description
Comorbidity decompensations at month 1 assessed by serum creatinine level measure
Time Frame
Month 1
Title
Comorbidity decompensations at month 1: Blood analysis of epidermal Growth Factor Receptor (eGFR)
Description
Comorbidity decompensations at month 1 assessed by eGFR measure
Time Frame
Month 1
Title
Comorbidity decompensations at month 1: Blood analysis of C reactive protein (CRP)
Description
Comorbidity decompensations at month 1 assessed by CRP measure
Time Frame
Month 1
Title
Comorbidity decompensations at month 1: Blood analysis of HbA1C
Description
Comorbidity decompensations at month 1 assessed by HbA1C measure
Time Frame
Month 1
Title
Comorbidity decompensations at month 1: Blood analysis of total cholesterol
Description
Comorbidity decompensations at month 1 assessed by total cholesterol measure
Time Frame
Month 1
Title
Comorbidity decompensations at month 1: Blood analysis of LDL cholesterol
Description
Comorbidity decompensations at month 1 assessed by HDL cholesterol measure
Time Frame
Month 1
Title
Comorbidity decompensations at month 1: Blood analysis of HDL cholesterol
Description
Comorbidity decompensations at month 1 assessed by HDL cholesterol measure
Time Frame
Month 1
Title
Comorbidity decompensations at month 1: Blood analysis of triglyceride
Description
Comorbidity decompensations at month 1 assessed by triglyceride measure
Time Frame
Month 1
Title
Comorbidity decompensations at month 1: Blood analysis of glycaemia
Description
Comorbidity decompensations at month 1 assessed by glycaemia measure
Time Frame
Month 1
Title
site injection reaction during day 0 to day 5: pain
Description
site injection reaction during day 0 to day 5 assessed by pain (0-10 scale VAS) measure
Time Frame
Dat 3 or day 5
Title
site injection reaction during day 0 to day 5: inflammatory reaction
Description
site injection reaction during day 0 to day 5 assessed by CRP level measure
Time Frame
Dat 3 or day 5
Title
site injection reaction during day 0 to day 5: swelling (yes/no)
Description
site injection reaction during day 0 to day 5 assessed by swelling (yes/no)
Time Frame
Dat 3 or day 5
Title
site injection reaction during day 0 to day 5: itching (yes/no)
Description
site injection reaction during day 0 to day 5 assessed by itching (yes/no)
Time Frame
Dat 3 or day 5
Title
site injection reaction during day 0 to day 5: redness (yes/no)
Description
site injection reaction during day 0 to day 5 assessed by redness (yes/no)
Time Frame
Dat 3 or day 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults aged over 18 years old Gout confirmed by identification of urate crystals by joint fluid or tophus analysis or by ultrasound of the affected joint and/or Gout according to Nijmegen criteria (presence of a score ≥ 8/13) depending on the following items: Man (2 pts) Previous crisis (2 pts) Involvement of first metatarsophalangeal joint (MTP1) (2.5 pts) Maximum pain within 24 hours (0.5pt) Redness (1 pt) HTA or cardiovascular disease (1.5 pts) SUL > 360 μmol/l during the crisis (3.5 pts) Chronic kidney disease stage 4/5 or renal transplantation Flare ≤ 5 days Pain assessed by visual analogical scale > 4/10 Exclusion Criteria: Participating in another trial including the administration of a drug Active infection History of anakinra or prednisone allergy Contra-indication of anakinra or prednisone Neutrophil count < 1000/mm3 (not due to ethnic cause) Difficulty understanding French Illiteracy Pregnant women or breastfeeding mothers (see PHC article L.1121-5) Persons deprived of liberty by judicial or administrative decision, persons receiving psychiatric care under Sections L. 3212-1 and L. 3213-1 and persons admitted to a health or social institution for purposes other than research (see CSP Article L.1121-6) Major persons subject to a measure of legal protection or unseeding to express consent (see PHC Article L.1121-8) Persons not affiliated to a social security plan or beneficiaries of such a plan (see PHC Article L.1121-8-1)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hang-Korng EA, PhD-MD
Phone
1 49 95 88 25
Ext
+33
Email
hang-korng.ea@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hang-Korng EA, PhD-MD
Organizational Affiliation
Hôpital Lariboisière
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rhumathology department
City
Paris
State/Province
Ile-De-France
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hang-Korng Pr EA, PHPU

12. IPD Sharing Statement

Learn more about this trial

Anakinra vs Prednisone to Treat Gout Flare in Patients With Chronic Kidney Disease Stage 4/5 or Renal Transplantation

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