Long-term Cardiovascular Risk Following Successful Renal Transplantation

Renal Transplant Clinical Trial

Official title:

The Prevalence of Cardiovascular Risk Factors in Patients More Than 10 Years Following Successful Renal Transplant.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01728012
• Other study ID #: REK2010/2926
• Status: Completed
• Phase: N/A
• First received: November 8, 2012
• Last updated: August 14, 2014
• Start date: November 2012
• Est. completion date: November 2013

Study information

• Verified date: August 2014
• Source: Helse Stavanger HF
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Data Protection AuthorityNorway: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Renal Transplant

Locations

Country	Name	City	State
Norway	Stavanger University Hospital	Stavanger

Sponsors (1)

Lead Sponsor	Collaborator
Helse Stavanger HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fibroblast growth factor 23 (FGF23)	To evaluate the long-term effect of a successful renal transplant on this biomarker.	More than 10 years after successful renal transplantation	No
Secondary	Intact parathyroid hormone (iPTH)	To evaluate the long-term effect of a successful renal transplant on this biomarker.	More than 10 years after successful renal transplantation	No
Secondary	Klotho	To evaluate the long-term effect of a successful renal transplant on this biomarker.	More than 10 years after successful renal transplantation	No
Secondary	Neutrophil gelatinase-associated lipocalin (NGAL)	To evaluate the long-term effect of a successful renal transplant on this biomarker.	More than 10 years after successful renal transplantation	No