Long-term Cardiovascular Risk Following Successful Renal Transplantation

Completed

• Conditions: Renal Transplant

• Registration Number: NCT01728012
• Lead Sponsor: Helse Stavanger HF

Brief Summary

Mineral metabolism disturbances occur early during the course of chronic kidney disease and eventually affect most patients. For how long such disturbances persist after a successful renal transplantation is mainly unknown. This study will investigate the prevalence of such disturbances in patients more than 10 years following a successful renal transplantation. The patients will be recruited from an existing registry in Norway.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-08
• Study First Submitted QC: 2012-11-12
• Study First Posted: 2012-11-16
• Primary Completion: 2013-10
• Study Completion: 2013-11
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-14
• Last Update Posted: 2014-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Registered in the Norwegian Renal Registry
• Documented elevated iPTH at Tx and 10 weeks post-tx
• Well functioning transplant 10 years following tx
• Signed informed consent

Exclusion Criteria

• Lack of ability to comply with the protocol
• Refused written informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fibroblast growth factor 23 (FGF23)	More than 10 years after successful renal transplantation	To evaluate the long-term effect of a successful renal transplant on this biomarker.

Secondary Outcome Measures

Name	Time	Method
Intact parathyroid hormone (iPTH)	More than 10 years after successful renal transplantation	To evaluate the long-term effect of a successful renal transplant on this biomarker.
Klotho	More than 10 years after successful renal transplantation	To evaluate the long-term effect of a successful renal transplant on this biomarker.
Neutrophil gelatinase-associated lipocalin (NGAL)	More than 10 years after successful renal transplantation	To evaluate the long-term effect of a successful renal transplant on this biomarker.

Trial Locations

Locations (1)

Stavanger University Hospital; 🇳🇴 Stavanger, Norway