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Randomized multicenter double-blind controlled trial comparing anakinra to prednisone for gout flare in patients with chronic kidney disease stage 4-5 or kidney transplantation
EU CTIS ID: 2024-514347-28-00
What this study is testing
To demonstrate the superiority of anakinra, the recombinant agonist of the interleukin-1 antagonist, versus prednisone in the prednisone in the treatment of gout attacks in patients with patients with chronic kidney disease stages 3b, 4 or 5, renal transplantation or dialysis.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult over 18 years old
- - Gout attack confirmed by demonstration of urate crystals by analysis of joint fluid or tophus or by ultrasound of the affected joint and/or - Gout attack according to Nijmegen criteria (presence of a score > 8/13) according to the following items: • Man (2 pts) • Previous crisis (2 pts) • Injury of the metatarsophalangeal joint of the first ray (MTP1) (2.5 pts) • Maximum installation in less than 24 hours (0.5pt) • Redness (1 pt) • Hypertension or cardiovascular diseases (1.5 pts) • Blood uric acid > 360 µmol/l during the crisis (3.5 pts)
- Persistent crisis
- EVA > 4/10
- Chronic kidney disease stages 3b, 4 or 5, or kidney transplant, or dialysis
- Affiliation to the French social security system or CMU
You likely can't join if
- Participation in another interventional trial including the administration of a drug
- Persons deprived of liberty by a judicial or administrative decision, persons subject to psychiatric care under articles L. 3212-1 and L. 3213-1 and persons admitted to a health or social establishment to others purposes other than research (Cf. CSP article L.1121-6)
- Adults subject to a legal protection measure or unable to express their consent (Cf. CSP article L.1121-8)
- Persons not affiliated to a social security scheme or beneficiaries of such a scheme (Cf. CSP article L.1121-8-1)
- Active infection
- Known allergy to anakinra or prednisone or their excipients
See the full eligibility criteria
- Adult over 18 years old
- - Gout attack confirmed by demonstration of urate crystals by analysis of joint fluid or tophus or by ultrasound of the affected joint and/or - Gout attack according to Nijmegen criteria (presence of a score > 8/13) according to the following items: • Man (2 pts) • Previous crisis (2 pts) • Injury of the metatarsophalangeal joint of the first ray (MTP1) (2.5 pts) • Maximum installation in less than 24 hours (0.5pt) • Redness (1 pt) • Hypertension or cardiovascular diseases (1.5 pts) • Blood uric acid > 360 µmol/l during the crisis (3.5 pts)
- Persistent crisis
- EVA > 4/10
- Chronic kidney disease stages 3b, 4 or 5, or kidney transplant, or dialysis
- Affiliation to the French social security system or CMU
- - Signature of informed, free and written consent for participation in the study
- Negative plasma pregnancy test and under effective contraception, namely hormonal contraception (Progesterone or combined Progesterone and estrogen orally, vaginally, intradermally, implant) or hormonal or mechanical IUD, in premenopausal women
- Participation in another interventional trial including the administration of a drug
- Persons deprived of liberty by a judicial or administrative decision, persons subject to psychiatric care under articles L. 3212-1 and L. 3213-1 and persons admitted to a health or social establishment to others purposes other than research (Cf. CSP article L.1121-6)
- Adults subject to a legal protection measure or unable to express their consent (Cf. CSP article L.1121-8)
- Persons not affiliated to a social security scheme or beneficiaries of such a scheme (Cf. CSP article L.1121-8-1)
- Active infection
- Known allergy to anakinra or prednisone or their excipients
- Contraindication to the administration of anakinra or prednisone
- Neutropenia < 1000 /mm3
- Chronic kidney disease ≤ 3a
- Difficulty understanding French
- Illiteracy
- Pregnant women, parturients or breastfeeding mothers (Cf. CSP article L.1121-5)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.