Long-term Cardiovascular Risk Following Successful Renal Transplantation

NCT01728012 | Completed

• 1 other identifier: REK2010/2926
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Transplant

Keywords

Successful transplantation; Long-term observation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Intact parathyroid hormone (iPTH)

  More than 10 years after successful renal transplantation

• Klotho

  More than 10 years after successful renal transplantation

• Neutrophil gelatinase-associated lipocalin (NGAL)

  More than 10 years after successful renal transplantation

Study Arms (2)

eGFR >=60ml/min/1.73m2

Patients with an estimated glomerular filtration rate of \>=60 ml/min/1.73m2.

eGFR 45-60ml/min/1.73m2

Patients with estimated glomerular filtration rate \>=45 ml/min/1.73m2 and \<60ml/min/1.73m2.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients registered in the Norwegian Renal Registry with transplan more than 10 years ago.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Helse Stavanger HF: lead

Study Sites (1)

Stavanger University Hospital

Stavanger, NO-4011, Norway

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and urine will be collected along with the clinical observations. Serum, plasma and urine will be frozen for later analyses.

Study Officials

• Inger Hjørdis Bleskestad, MD

  Helse Stavanger HF

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2012
• First Posted: November 16, 2012
• Study Start: November 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: November 1, 2013
• Last Updated: August 15, 2014

Record last verified: 2014-08

Locations

NO (1)