NCT04399915

Brief Summary

The current study primarily aimed to characterize the oxalate and uric acid metabolism in CKD patients and to analyze its association with renal survival prognosis. Secondarily, the study is planned to determine whether hyperoxalemia and hyperuricemia are independent risk factors for cardiovascular events and mortality.

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
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

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

Study Start

First participant enrolled

January 10, 2019

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 19, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 22, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

May 22, 2020

Status Verified

May 1, 2020

Enrollment Period

2.9 years

First QC Date

May 19, 2020

Last Update Submit

May 19, 2020

Conditions

CKDESRDHyperuricemiaOxaluria

Keywords

CKDhemodialysisperitoneal dialysisoxalateuric acidmetabolismrenal survivalcardio-vascular events

Outcome Measures

Primary Outcomes (1)

  • Renal Survival for CKD stages 1-3

    3 years

Secondary Outcomes (1)

  • Cardio-vascular Events

    3 years

Study Arms (3)

Hyperoxalemia/Hyperuricemia Group

Hyperoxalemia/Hyperuricemia-free Group

Healthy Subjects

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

CKD stage 1-5 patients

You may qualify if:

  • age \>18 years old,
  • CKD stage 1-4,
  • the patients did not take antibiotics and/or probiotics, lipid- and/or urate-lowering therapy for at least past 3 months or:
  • dialysis treatment for at least 3 months,
  • a stable clinical condition and adequately functioning arteriovenous fistula or peritoneal access,
  • a target level of Kt/V (≥ 1.4 for the HD patients and ≥1.7 for the PD patients).

You may not qualify if:

  • hospitalization in the preceding 3 months,
  • previous history or actual diagnosis of peritonitis, anemia, systemic and malignant diseases, acute inflammation processes, immunosuppressive treatment and active hepatitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Natalia Stepanova

Kyiv, 04050, Ukraine

RECRUITING

MeSH Terms

Conditions

Kidney Failure, ChronicHyperuricemiaHyperoxaluria

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2020

First Posted

May 22, 2020

Study Start

January 10, 2019

Primary Completion

December 1, 2021

Study Completion

December 1, 2024

Last Updated

May 22, 2020

Record last verified: 2020-05

Locations

UA(1)