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

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ClinicalTrials.gov Identifier: NCT03336203
Recruitment Status : Recruiting
First Posted : November 8, 2017
Last Update Posted : November 17, 2017
Sponsor:
Collaborator:
Dr. T. Bevzenko, Dr. O. Synyachenko, Dr. I. Golovach
Information provided by (Responsible Party):
Medical Practice Prof D. Ivanov

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. 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.

Condition or disease Intervention/treatment Phase
Gout CKD Stage 1-4 SUA Level (>8 mg/dL; 480 µmol/L) Drug: Febuxostat 80 MG Oral Tablet or Allopurinol 300 MG Oral Tablet Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Impact of Urate-lowering Therapy on Kidney Function in Patients With/Without Gout
Actual Study Start Date : October 30, 2017
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gout

Arm Intervention/treatment
Active Comparator: Hyperurecemia with gout
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
treatment either with allopurinol or febuxostat

Active Comparator: Hyperurecemia without gout
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
treatment either with allopurinol or febuxostat




Primary Outcome Measures :
  1. Clinical reduction of new onset of acute gout attacks [ Time Frame: 30 months ]
    number of attacks

  2. Estimating CKD prognosis by eGFR [ Time Frame: 30 months ]
    eGFR (every 6 months)

  3. Estimating CKD prognosis by Albuminuria [ Time Frame: 30 months ]
    Albuminuria level (every 6 months)


Secondary Outcome Measures :
  1. cardiovascular risk diminution [ Time Frame: 30 months ]
    number of all cases of cardiovascular mortality

  2. nervous system status [ Time Frame: 30 months ]
    number of clinical side effects affecting nervous system



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03336203


Contacts
Contact: Dmytro D Ivanov, MD, PhD, DSC, Prof +380504448788 ivanovdd@i.kiev.ua
Contact: Tatyana B Bevzenko, MD, PhD +380688659594 tanya.bevzenko@gmail.com

Locations
Ukraine
Medical Practice Prof D.Ivanov Recruiting
Kiev, Ukraine, 01014
Contact: Dmytro Ivanov, MD, Prof    504448788    ivanovdd@i.kiev.ua   
Sub-Investigator: Tatyana B Bevzenko, MD, PhD         
Sub-Investigator: Oleg B Synyachenko, MD, PhD, Prof         
Sub-Investigator: Iryna Yu Golovach, MD, PhD, Prof         
Sponsors and Collaborators
Medical Practice Prof D. Ivanov
Dr. T. Bevzenko, Dr. O. Synyachenko, Dr. I. Golovach

Additional Information:
Responsible Party: Medical Practice Prof D. Ivanov
ClinicalTrials.gov Identifier: NCT03336203     History of Changes
Other Study ID Numbers: MPIvanov
First Posted: November 8, 2017    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: After finishing trial and results omtained - yes

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Medical Practice Prof D. Ivanov:
eGFR, gout, CKD, uric acid, uric acid lowering therapy, hyperuricemia, allopurinol, febuxostat

Additional relevant MeSH terms:
Allopurinol
Febuxostat
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs