NCT04844814SuspendedPhase 2
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
Source: ClinicalTrials.gov · Last updated 4 Feb 2026
Reason given: Peremption of treatments, difficulty of patients recrutment (28 patients in 3 years) and lack of funding to pursue the study.
Brief summary (registry, in English)
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.
- Status (registry)
- Suspended
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 204 (estimated)
- First submitted
- 24 Jan 2021
- Start date
- 2 Jun 2022
- Primary completion date
- 12 Feb 2025
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Chronic kidney disease
- NCT number
- NCT04844814
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participating in another trial including the administration of a drug
- 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)
Other illness
- Active infection
- History of anakinra or prednisone allergy
Lab values
- Neutrophil count < 1000/mm3 (not due to ethnic cause)
Other
- Contra-indication of anakinra or prednisone
- Difficulty understanding French
- Illiteracy
- Pregnant women or breastfeeding mothers (see PHC article L.1121-5)
- 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)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rhumathology department | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.