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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01728012
Other study ID # REK2010/2926
Secondary ID
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


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
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