GoutPhase 2Ana4CKDNCT04844814
Anakinra vs Prednisone to Treat Gout Flare in Patients With Chronic Kidney Disease Stage 4/5 or Renal Transplantation
A Phase 2 study testing Anakinra 100Mg/0.67Ml Inj Syringe and Prednisone in people with Gout and Chronic Kidney Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gout, Chronic Kidney Disease, Renal Transplantation
- What is being tested?
- Anakinra 100Mg/0.67Ml Inj Syringe and Prednisone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jun 2022to 31 Aug 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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
- Being tested
- Anakinra 100Mg/0.67Ml Inj Syringe, Prednisone, Placebo of Prednisone, Placebo of Anakinra
- Keywords
- Gout, Flare, Urate crystals, Chronic kidney disease, Anakinra, IL-1b, Corticosteroid, Renal transplantation
- Medical subject headings
- Gout, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anakinra 100Mg/0.67Ml Inj SyringeDrug
Anakinra 100 mg/d subcutaneous injection
PrednisoneDrug
Prednisone 30 mg/d
Placebo of PrednisoneDrug
Placebo of Prednisone
Placebo of AnakinraDrug
Placebo of Anakinra
| Study group | Role | What they receive |
|---|---|---|
| Anakinra | Experimental | Anakinra 100 mg/d+Placebo of Prednisone Receives: Drug: Anakinra 100Mg/0.67Ml Inj Syringe; Drug: Placebo of Prednisone |
| Prednisone | Active comparator | Prednisone 30 mg/d+Placebo of Anakinra Receives: Drug: Prednisone; Drug: Placebo of Anakinra |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 3
Secondary outcomes (29)
Percentage of responders (improvement ≥ 50%) at day 5
Percentage of responders (improvement ≥ 50%) at day 5
Measured: Day 5
Percentage of flare resolution (improvement ≥ 80%) at day 5
Percentage of flare resolution (improvement ≥ 80%) at day 5
Measured: Day 5
Time to treatment response
Time to treatment response
Measured: Day 3 or Day 5
Time to flare resolution
Time to flare resolution
Measured: Day 3 or Day 5
Treatment duration
Treatment duration
Measured: Day3 or Day 5
Duration of hospitalization
Duration of hospitalization
Measured: Day 3 or Day 5
Healthcare consumption at month 1 : number of consultations and hospitalizations related to gout flare
Healthcare consumption at month 1 assessed by number of consultations and hospitalizations related to gout flare
Measured: Month 1
Healthcare consumption at month 1: total hospital stay
Healthcare consumption at month 1 assessed by total hospital stay
Measured: Month 1
Healthcare consumption at month 1
Healthcare consumption at month 1 assessed by number and cumulative duration of sick leave related to gout
Measured: Month 1
Side effects
Side effects
Measured: Month 1
Comorbidity decompensations at month 1 : DT2 decompensation
Comorbidity decompensations at month 1 assessed by DT2 decompensation measure
Measured: Month 1
Comorbidity decompensations at month 1: Blood pressure
Comorbidity decompensations at month 1 assessed by Blood pressure measure
Measured: Month 1
Comorbidity decompensations at month 1: Hypertension
Comorbidity decompensations at month 1 assessed by hypertension measure
Measured: Month 1
Comorbidity decompensations at month 1: Weight
Comorbidity decompensations at month 1 assessed by Weight measure
Measured: Month 1
Comorbidity decompensations at month 1: number of Cardiovascular events : coronary disease, heart attack, stroke
Comorbidity decompensations at month 1 assessed by number of Cardiovascular events : coronary disease, heart attack, stroke
Measured: Month 1
Comorbidity decompensations at month 1: Blood analysis of serum creatinine level
Comorbidity decompensations at month 1 assessed by serum creatinine level measure
Measured: Month 1
Comorbidity decompensations at month 1: Blood analysis of epidermal Growth Factor Receptor (eGFR)
Comorbidity decompensations at month 1 assessed by eGFR measure
Measured: Month 1
Comorbidity decompensations at month 1: Blood analysis of C reactive protein (CRP)
Comorbidity decompensations at month 1 assessed by CRP measure
Measured: Month 1
Comorbidity decompensations at month 1: Blood analysis of HbA1C
Comorbidity decompensations at month 1 assessed by HbA1C measure
Measured: Month 1
Comorbidity decompensations at month 1: Blood analysis of total cholesterol
Comorbidity decompensations at month 1 assessed by total cholesterol measure
Measured: Month 1
Comorbidity decompensations at month 1: Blood analysis of LDL cholesterol
Comorbidity decompensations at month 1 assessed by HDL cholesterol measure
Measured: Month 1
Comorbidity decompensations at month 1: Blood analysis of HDL cholesterol
Comorbidity decompensations at month 1 assessed by HDL cholesterol measure
Measured: Month 1
Comorbidity decompensations at month 1: Blood analysis of triglyceride
Comorbidity decompensations at month 1 assessed by triglyceride measure
Measured: Month 1
Comorbidity decompensations at month 1: Blood analysis of glycaemia
Comorbidity decompensations at month 1 assessed by glycaemia measure
Measured: Month 1
site injection reaction during day 0 to day 5: pain
site injection reaction during day 0 to day 5 assessed by pain (0-10 scale VAS) measure
Measured: Dat 3 or day 5
site injection reaction during day 0 to day 5: inflammatory reaction
site injection reaction during day 0 to day 5 assessed by CRP level measure
Measured: Dat 3 or day 5
site injection reaction during day 0 to day 5: swelling (yes/no)
site injection reaction during day 0 to day 5 assessed by swelling (yes/no)
Measured: Dat 3 or day 5
site injection reaction during day 0 to day 5: itching (yes/no)
site injection reaction during day 0 to day 5 assessed by itching (yes/no)
Measured: Dat 3 or day 5
site injection reaction during day 0 to day 5: redness (yes/no)
site injection reaction during day 0 to day 5 assessed by redness (yes/no)
Measured: Dat 3 or day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start2 Jun 2022
- Primary completion12 Feb 2025
- Study completion31 Aug 2026 (estimated)
Why it stopped: Peremption of treatments, difficulty of patients recrutment (28 patients in 3 years) and lack of funding to pursue the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GoutStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hang-Korng EA, PhD-MD, Principal investigator, Hopital Lariboisière
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04844814
- Sponsor's protocol ID
- APHP180560
- Acronym
- Ana4CKD
- Status last verified
- Feb 2026
- First submitted
- 24 Jan 2021
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04844814
- Acronym / sponsor ID
- Ana4CKD / APHP180560
- Conditions
- Gout, Chronic Kidney Disease, Renal Transplantation
- Keywords
- Gout, Flare, Urate crystals, Chronic kidney disease, Anakinra, IL-1b, Corticosteroid, Renal transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Peremption of treatments, difficulty of patients recrutment (28 patients in 3 years) and lack of funding to pursue the study.
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 2 Jun 2022 (actual)
- Primary completion
- 12 Feb 2025 (actual)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 14 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anakinra | Experimental | Drug: Anakinra 100Mg/0.67Ml Inj Syringe, Drug: Placebo of PrednisoneAnakinra 100 mg/d+Placebo of Prednisone |
| Prednisone | Active comparator | Drug: Prednisone, Drug: Placebo of AnakinraPrednisone 30 mg/d+Placebo of Anakinra |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anakinra 100Mg/0.67Ml Inj SyringeAnakinra 100 mg/d subcutaneous injection | Drug | Anakinra |
| PrednisonePrednisone 30 mg/d | Drug | Prednisone |
| Placebo of PrednisonePlacebo of Prednisone | Drug | Anakinra |
| Placebo of AnakinraPlacebo of Anakinra | Drug | Prednisone |
Primary outcome
Pain difference between Day 3 and treatment initiation
Time frame: Day 3
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
29 secondary outcomes
Percentage of responders (improvement ≥ 50%) at day 5
Time frame: Day 5
Percentage of flare resolution (improvement ≥ 80%) at day 5
Time frame: Day 5
Time to treatment response
Time frame: Day 3 or Day 5
Time to flare resolution
Time frame: Day 3 or Day 5
Treatment duration
Time frame: Day3 or Day 5
Duration of hospitalization
Time frame: Day 3 or Day 5
Healthcare consumption at month 1 : number of consultations and hospitalizations related to gout flare
Time frame: Month 1
Healthcare consumption at month 1: total hospital stay
Time frame: Month 1
Healthcare consumption at month 1
Time frame: Month 1
Side effects
Time frame: Month 1
Comorbidity decompensations at month 1 : DT2 decompensation
Time frame: Month 1
Comorbidity decompensations at month 1: Blood pressure
Time frame: Month 1
Comorbidity decompensations at month 1: Hypertension
Time frame: Month 1
Comorbidity decompensations at month 1: Weight
Time frame: Month 1
Comorbidity decompensations at month 1: number of Cardiovascular events : coronary disease, heart attack, stroke
Time frame: Month 1
Comorbidity decompensations at month 1: Blood analysis of serum creatinine level
Time frame: Month 1
Comorbidity decompensations at month 1: Blood analysis of epidermal Growth Factor Receptor (eGFR)
Time frame: Month 1
Comorbidity decompensations at month 1: Blood analysis of C reactive protein (CRP)
Time frame: Month 1
Comorbidity decompensations at month 1: Blood analysis of HbA1C
Time frame: Month 1
Comorbidity decompensations at month 1: Blood analysis of total cholesterol
Time frame: Month 1
Comorbidity decompensations at month 1: Blood analysis of LDL cholesterol
Time frame: Month 1
Comorbidity decompensations at month 1: Blood analysis of HDL cholesterol
Time frame: Month 1
Comorbidity decompensations at month 1: Blood analysis of triglyceride
Time frame: Month 1
Comorbidity decompensations at month 1: Blood analysis of glycaemia
Time frame: Month 1
site injection reaction during day 0 to day 5: pain
Time frame: Dat 3 or day 5
site injection reaction during day 0 to day 5: inflammatory reaction
Time frame: Dat 3 or day 5
site injection reaction during day 0 to day 5: swelling (yes/no)
Time frame: Dat 3 or day 5
site injection reaction during day 0 to day 5: itching (yes/no)
Time frame: Dat 3 or day 5
site injection reaction during day 0 to day 5: redness (yes/no)
Time frame: Dat 3 or day 5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
Related trials for Gout
RecruitingPhase 4
Treat-to-Target Serum Urate Versus Treat-to-Avoid Symptoms in Gout
Gout
RecruitingPhase 3
A Study of Dotinurad Versus Allopurinol in Participants With Gout
Gout
RecruitingPhase 3
A Study of Dotinurad Versus Allopurinol in Tophaceous Gout
Tophaceous Gout
Not yet recruitingPhase 3
Combined Metabolic Activator Supplementation in Subjects Diagnosed With Gout
Gout Disease
Enrolling by invitation
The Remote Monitoring of Gout Study
Gout Initiating Urate-loweringUrate-lowering Therapy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hang-Korng EA, PhD-MD principal investigator
Hopital Lariboisière
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anakinra 100Mg/0.67Ml Inj Syringe and Prednisone in people with Gout and Chronic Kidney Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain difference between Day 3 and treatment initiation (time frame: Day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.