NCT03336203

Brief Summary

This trial aims to investigate the impact of two target levels uric acid-lowering therapy (ULT) caused by hyperuricemia (HU) on kidney function and CKD progression \[1\] measured by eGFR and albuminuria (A) \[2\]. The main current tasks include 1) estimation serum uric acid (SUA) level most potential preserving of kidney function 2) the new onset of gouts depending on SUA level, both in gouts' and CKD' objects 3) safety and side effects of target and ultralow SUA levels for evidence-based ULT optimal regime in CKD and non CKD with gout patients. 4) investigation of cardio vascular rick ratio depending on SUA level. The tasks also include

  1. 1.to determine U-curve or directly proportional relationship between SUA and eGFR-EPI in CKD 1-4
  2. 2.to evaluate the new onset of goat which depends on SUA level and renal function In this study the optimal ULT for kidney function based on target SUA level in 30 months' treatment with either allopurinol or febuxostat will be determined.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2017

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2017

Completed
23 days until next milestone

Study Start

First participant enrolled

October 30, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 8, 2017

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

August 24, 2022

Status Verified

August 1, 2022

Enrollment Period

5.1 years

First QC Date

October 7, 2017

Last Update Submit

August 22, 2022

Conditions

GoutCKD Stage 1-4SUA Level (>8 mg/dL; 480 µmol/L)

Keywords

eGFR, gout, CKD, uric acid, uric acid lowering therapy, hyperuricemia, allopurinol, febuxostat

Outcome Measures

Primary Outcomes (3)

  • Clinical reduction of new onset of acute gout attacks

    number of attacks

    30 months

  • Estimating CKD prognosis by eGFR

    eGFR (every 6 months)

    30 months

  • Estimating CKD prognosis by Albuminuria

    Albuminuria level (every 6 months)

    30 months

Secondary Outcomes (2)

  • cardiovascular risk diminution

    30 months

  • nervous system status

    30 months

Study Arms (2)

Hyperurecemia with gout

ACTIVE COMPARATOR

90 patients with high SUA level (\>8 mg/dL; 480 µmol/L) with gout (EULAR's criteria) are going to be treated with allopurinol 300 mg oral tab or febuxostat 80 vg oral tab to achive target SUA levels as 5 mg/dL (300 µmol/L) and ultralow SUA \<3 mg/dL (180 µmol/L)

Drug: Febuxostat 80 MG Oral Tablet or Allopurinol 300 MG Oral Tablet

Hyperurecemia without gout

ACTIVE COMPARATOR

90 patients with high SUA level (\>8 mg/dL; 480 µmol/L) withot gout (EULAR's criteria) but with CKD are going to be treated with allopurinol 300 mg oral tab or febuxostat 80 vg oral tab to achive target SUA levels as 5 mg/dL (300 µmol/L) and ultralow SUA \<3 mg/dL (180 µmol/L)

Drug: Febuxostat 80 MG Oral Tablet or Allopurinol 300 MG Oral Tablet

Interventions

Febuxostat 80 MG Oral Tablet or Allopurinol 300 MG Oral TabletDRUG

treatment either with allopurinol or febuxostat

Hyperurecemia with goutHyperurecemia without gout

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • outpatient adults withgout and hyperurecemia (SUA level above 8 mg/dL (480 µmol/L)
  • outpatient adults with CKD 1-4 stages and hyperurecemia (SUA level above 8 mg/dL (480 µmol/L)

You may not qualify if:

  • CKD 5 stage
  • heart failure III-IV NYHA
  • stroke
  • peripheral arterial disease
  • obesity with BMI above 30 kg/m2
  • hypertension 3 grade
  • insulin-dependent DM
  • any kind of cancer
  • inpatient intensive unit patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Practice Prof D.Ivanov

Kiev, 01014, Ukraine

Location

Related Links

MeSH Terms

Conditions

GoutHyperuricemia

Interventions

FebuxostatTabletsAllopurinol

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesCrystal ArthropathiesRheumatic DiseasesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDosage FormsPharmaceutical PreparationsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 180 participants in parallel groups. These patients with high SUA level (\>8 mg/dL; 480 µmol/L) are going to be divided into 2 arms (90+90) 1) with gout (EULAR's criteria) and 2) without gout but with presence of CKD 1-4)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2017

First Posted

November 8, 2017

Study Start

October 30, 2017

Primary Completion

December 1, 2022

Study Completion

December 31, 2022

Last Updated

August 24, 2022

Record last verified: 2022-08

Locations

UA(1)