NCT01317173

Brief Summary

Chronic kidney disease is a progressive disorder that has been influenced with many factors. Most of the patients has altered Ca P metabolism and these dis orders are the contributing factors of the disease progression. It has been recently documented that FGF23 and Klotho are the key factors of PTH secretion Ca-P metabolism. This study aimed to evaluate the impact of Klotho and FGF23 on the progression of stage 3-4 chronic kidney disease.

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
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2008

Typical duration 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

March 1, 2008

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

March 16, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

March 17, 2011

Status Verified

January 1, 2011

Enrollment Period

3.2 years

First QC Date

March 16, 2011

Last Update Submit

March 16, 2011

Conditions

Chronic Kidney Disease

Keywords

Chronic kidney disease progressionFGF 23Klotho

Outcome Measures

Primary Outcomes (1)

  • Progression of kidney disease

    Doubling of creatinin, requirement of renal replacement therapy

    continuous measurement of kidney functions 3 monthly for two years or until the outcome reached

Secondary Outcomes (1)

  • Evaluation of Ca P metabolism

    3 monthly for two years or until the outcome reached

Study Arms (2)

Progressive disease

Serum creatinin level rise more than 2 times

Non-progressive disease

Serum creatinin level rise less than 2 times

Eligibility Criteria

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

Patients diagnosed with non-diabetic chronic kidney disease between the ages of 18 and 65 years old.

You may qualify if:

  • Non-diabetic chronic kidney disease

You may not qualify if:

  • Presence of DM
  • Actively using calcium based phosphorus binder of vitamin D

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Education and Research Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal 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
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

March 16, 2011

First Posted

March 17, 2011

Study Start

March 1, 2008

Primary Completion

May 1, 2011

Study Completion

June 1, 2011

Last Updated

March 17, 2011

Record last verified: 2011-01

Locations

TU(1)