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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01293786
Other study ID # 03-02-2011
Secondary ID
Status Completed
Phase N/A
First received February 10, 2011
Last updated May 25, 2011
Start date February 2011
Est. completion date May 2011

Study information

Verified date May 2011
Source Ramathibodi Hospital
Contact n/a
Is FDA regulated No
Health authority Thailand: Mahidol University
Study type Observational

Clinical Trial 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.


Description:

Kidney transplantation (KT) improved quality of life and longevity of CKD patients. Nevertheless, kidney function deteriorates overtime in a manner not different from CKD counterparts. Hypomagnesemia is prevalent in KT recipients secondary to immunosuppressive therapy. In addition to serum calcium, phosphate and elemental calcium intake, the relationship between low serum magnesium and vascular calcification (VC) has been observed in small studies in CKD. Whether low serum magnesium associates with VC in KT has never been elucidated. The present study compares vascular calcification between KT and CKD and its association with serum magnesium.


Recruitment information / eligibility

Status Completed
Enrollment 400
Est. completion date May 2011
Est. primary completion date May 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- acute kidney injury

- parathyroidectomy

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional


Locations

Country Name City State
Thailand Faculty of Medicine, Ramathibodi Hospital, Mahidol University Phayathai Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Ramathibodi Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary The difference in vascular calcification score between KT and CKD Baseline No
Secondary The association of serum magnesium with vascular calcification in KT Baseline No
Secondary The association of serum magnesium with vascular calcification in CKD Baseline No
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