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

Last updated: March 28, 2025
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Suspended

Phase

2

Condition

Collagen Vascular Diseases

Focal Segmental Glomerulosclerosis

Nephropathy

Treatment

Placebo of Anakinra

Anakinra 100Mg/0.67Ml Inj Syringe

Prednisone

Clinical Study ID

NCT04844814
APHP180560
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults aged over 18 years old

  • Gout confirmed by identification of urate crystals by joint fluid or tophus analysisor by ultrasound of the affected joint and/or

  • Gout according to Nijmegen criteria (presence of a score ≥ 8/13) depending on thefollowing 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 3b/4/5 or renal transplantation

  • Flare ≤ 5 days

  • Pain assessed by visual analogical scale > 4/10

Exclusion

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, personsreceiving psychiatric care under Sections L. 3212-1 and L. 3213-1 and personsadmitted to a health or social institution for purposes other than research (see CSPArticle L.1121-6)

  • Major persons subject to a measure of legal protection or unseeding to expressconsent (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)

Study Design

Total Participants: 204
Treatment Group(s): 4
Primary Treatment: Placebo of Anakinra
Phase: 2
Study Start date:
June 02, 2022
Estimated Completion Date:
March 12, 2026

Study 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.

Connect with a study center

  • Rhumathology department

    Paris, Ile-De-France 75010
    France

    Site Not Available

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