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The Impact of Urate-lowering Therapy on Kidney Function (IMPULsKF)

NCT03336203 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2022-08-24

No results posted yet for this study

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. to determine U-curve or directly proportional relationship between SUA and eGFR-EPI in CKD 1-4
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.

Conditions

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

Interventions

DRUG

Febuxostat 80 MG Oral Tablet or Allopurinol 300 MG Oral Tablet

treatment either with allopurinol or febuxostat

Sponsors & Collaborators

  • Medical Practice Prof D. Ivanov

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-30
Primary Completion
2022-12-01
Completion
2022-12-31

Countries

  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03336203 on ClinicalTrials.gov