NCT00696605

Brief Summary

The are 2 principal goals in this study:

  1. 1.To measure plasma copeptin levels in healthy subjects and to correlate them with plasma AVP concentrations and urine osmolalities in iso-, hypo-, and hyperosmolar states.
  2. 2.To measure plasma copeptin concentrations in patients with chronic renal failure under the same conditions described above, in order to characterize the impact of renal function on circulating copeptin levels in correlation to plasma AVP and urine osmolality.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2008

Completed
19 days until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

February 27, 2017

Status Verified

February 1, 2017

Enrollment Period

6 months

First QC Date

June 10, 2008

Last Update Submit

February 23, 2017

Conditions

HypoosmolalityHyperosmolalityRenal Failure

Keywords

HypoosmolalityHyperosmolalityCopeptinVasopressin

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy volunteers; patients with chronic renal failure

You may qualify if:

  • chronic renal failure grade I through IV
  • healthy age-matched controls

You may not qualify if:

  • chronic renal failure grade V
  • heart failure
  • liver disease
  • nephrotic syndrome
  • anemia (hemoglobin level \< 100 g/L)
  • uncontrolled hypertension (systolic BP \> 160 mmHg; diastolic BP \> 95 mm Hg)
  • coexisting severe disease
  • known thyroid disease
  • known hypocortisolism
  • known hypercortisolism
  • known diabetes insipidus
  • pregnancy
  • lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic of Internal Medicine, Hospital Center

Biel/Bienne, 2501, Switzerland

Location

Related Publications (1)

  • Balanescu S, Kopp P, Gaskill MB, Morgenthaler NG, Schindler C, Rutishauser J. Correlation of plasma copeptin and vasopressin concentrations in hypo-, iso-, and hyperosmolar States. J Clin Endocrinol Metab. 2011 Apr;96(4):1046-52. doi: 10.1210/jc.2010-2499. Epub 2011 Feb 2.

    PMID: 21289257DERIVED

MeSH Terms

Conditions

Renal InsufficiencyDiabetes Insipidus

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPituitary DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

June 10, 2008

First Posted

June 12, 2008

Study Start

July 1, 2008

Primary Completion

January 1, 2009

Study Completion

October 1, 2009

Last Updated

February 27, 2017

Record last verified: 2017-02

Locations

CH(1)