NCT03336203: IMPULsKF

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

Status unknown Phase 4 Last updated 24 August 2022

What this trial tests

Phase 4 trial testing Febuxostat 80 MG Oral Tablet or Allopurinol 300 MG Oral Tablet in Gout in 2 participants. Status unknown.

Timeline

30 October 2017

Primary endpoint
1 December 2022

31 December 2022

Quick facts

Lead sponsor	Medical Practice Prof D. Ivanov
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	2
Start date	30 October 2017
Primary completion	1 December 2022
Estimated completion	31 December 2022
Sites	1 location across Ukraine

Drugs / interventions tested

• Febuxostat 80 MG Oral Tablet or Allopurinol 300 MG Oral Tablet — full drug profile →

Conditions studied

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

Sponsor

Medical Practice Prof D. Ivanov — full company profile →

Who can join

Adults 18 to 75, any sex, with Gout or CKD Stage 1-4. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effects of Febuxostat on Mortality and Cardiovascular Outcomes: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
   Al-Abdouh A, Khan SU, Barbarawi M, Upadhrasta S, et al · · 2020 · cited 9× · PMID 32793871 · DOI 10.1016/j.mayocpiqo.2020.04.012