NCT01293786

Brief Summary

Both Kidney transplantation (KT) and Chronic Kidney Disease (CKD) patients have reduced kidney function. Low serum magnesium is more prevalent in KT recipients. The present study examines the difference in vascular calcification between KT and CKD and its association with serum magnesium.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 2011

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

May 26, 2011

Status Verified

May 1, 2011

Enrollment Period

3 months

First QC Date

February 10, 2011

Last Update Submit

May 25, 2011

Conditions

Vascular CalcificationChronic Kidney Disease

Keywords

magnesiumkidney transplantationhypomagnesemia

Outcome Measures

Primary Outcomes (1)

  • The difference in vascular calcification score between KT and CKD

    Baseline

Secondary Outcomes (2)

  • The association of serum magnesium with vascular calcification in KT

    Baseline

  • The association of serum magnesium with vascular calcification in CKD

    Baseline

Study Arms (2)

Kidney transplant recipients

Chronic kidney disease

Eligibility Criteria

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

Kidney transplant recipients and predialysis chronic kidney disease patients from outpatient nephrology clinic of Ramathibodi hospital, Mahidol University

You may qualify if:

  • kidney transplant recipients at least 1 year post surgery
  • predialysis chronic kidney disease with serum creatinine \> 1.1 mg/dL in female and 1.3 mg/dL in male

You may not qualify if:

  • acute kidney injury
  • parathyroidectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Ramathibodi Hospital, Mahidol University

Phayathai, Bangkok, 10400, Thailand

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Vascular CalcificationRenal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

CalcinosisCalcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sinee Disthabanchong, MD

    Ramathibodi Hospital, Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 10, 2011

First Posted

February 11, 2011

Study Start

February 1, 2011

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

May 26, 2011

Record last verified: 2011-05

Locations

TH(1)