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

NCT04844814 | Suspended Phase 2

• 1 other identifier: APHP180560
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Transplantation; Gout; Chronic Kidney Disease

Keywords

Gout; Flare; Urate crystals; Chronic kidney disease; Anakinra; IL-1b; Corticosteroid; Renal transplantation

Outcome Measures

Primary Outcomes (1)

• 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

  Day 3

Secondary Outcomes (29)

• Percentage of responders (improvement ≥ 50%) at day 5

  Day 5

• Percentage of flare resolution (improvement ≥ 80%) at day 5

  Day 5

• Time to treatment response

  Day 3 or Day 5

• Time to flare resolution

  Day 3 or Day 5

• Treatment duration

  Day3 or Day 5

Study Arms (2)

Anakinra

EXPERIMENTAL

Anakinra 100 mg/d+Placebo of Prednisone

Drug: Anakinra 100Mg/0.67Ml Inj Syringe; Drug: Placebo of Prednisone

Prednisone

ACTIVE COMPARATOR

Prednisone 30 mg/d+Placebo of Anakinra

Drug: Prednisone; Drug: Placebo of Anakinra

Interventions

Anakinra 100Mg/0.67Ml Inj Syringe DRUG

Anakinra 100 mg/d subcutaneous injection

Anakinra

Prednisone DRUG

Prednisone 30 mg/d

Prednisone

Placebo of Prednisone DRUG

Placebo of Prednisone

Anakinra

Placebo of Anakinra DRUG

Placebo of Anakinra

Prednisone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 3b/4/5 or renal transplantation
• Flare ≤ 5 days
• Pain assessed by visual analogical scale \> 4/10

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Rhumathology department

Paris, Île-de-France Region, 75010, France

Location

MeSH Terms

Conditions

Gout; Renal Insufficiency, Chronic

Interventions

Interleukin 1 Receptor Antagonist Protein; Prednisone

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Hang-Korng EA, PhD-MD

  Hôpital Lariboisière

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2021
• First Posted: April 14, 2021
• Study Start: June 2, 2022
• Primary Completion: February 12, 2025
• Study Completion (Estimated): August 31, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

FR (1)