NCT04844814

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

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

• Status: Suspended
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 204 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gout
• Chronic Kidney Disease
• Renal Transplantation

Interventions

Type	Name	Description
DRUG	Anakinra 100Mg/0.67Ml Inj Syringe	Anakinra 100 mg/d subcutaneous injection
DRUG	Prednisone	Prednisone 30 mg/d
DRUG	Placebo of Prednisone	Placebo of Prednisone
DRUG	Placebo of Anakinra	Placebo of Anakinra

Timeline

• Start date: 2022-06-02
• Primary completion: 2025-02-12
• Completion: 2026-08-31
• First posted: 2021-04-14
• Last updated: 2026-02-04

Locations

1 site across 1 country: France