Skip to main content
OpenTrials
Completed

NCT Number: NCT00698360

Circadian Rhythm of Erythropoietin And Melatonin in Renal Disease

Rationale: Investigation of the circadian rhythm of erythropoietin and melatonin in patients with various degrees of renal insufficiency

Objectives:

Primary objective: Is there a circadian rhythm of epo and melatonin in patients with various degrees of renal insufficiency?

Primary Objective: Is there a circadian rhythm of epo and melatonin in patients with various degrees of renal insufficiency compared to patients with a normal renal function?

Secondary Objective: Is there a circadian rhythm of cortisol and IGF in patients with various degrees of renal insufficiency?

Secondary Objective: Is there a circadian rhythm of cortisol and IGF in patients with various degrees of renal insufficiency compared to patients with a normal renal function?

Study design: Comparative study in 4 groups with various degrees of renal insufficiency, duration for each patient 24 hrs. Total duration of study 12 months, patients admitted to the hospital (on nursing ward)

Study population: Patients with various degrees of renal insufficiency

Main study parameters/endpoints: Analysis of the existence of a circadian rhythm in patients with a normal renal function and in patients with variable degrees of renal insufficiency

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Better knowledge of the circadian rhythm in renal insufficiency. This could lead to a more efficient administration of erythropoietin and melatonin in the future.

Extent of burden is 1 venapunction for placement of infusion needle, the withdrawal of 11 times 5 ml blood in 24 hrs, continuous measurement of body temperature via capsule, 24-hour continuous ambulant blood pressure monitoring.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Meander Medical Center

Amersfoort, 3818 ES, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient with various degrees of renal insufficiency, stable creatinin clearance: minimum 10 ml/min (measured with MDRD), admitted to our hospital
  • Informed Consent
  • Man/Women between 18 and 85 years
  • Understanding and knowledge of the dutch language

Exclusion criteria

  • Instable angina pectoris, heart failure NYHA class IV
  • Therapy with erythropoetin, melatonin and hypnotics
  • Acute renal failure or rapidly progressive glomerulonephritis
  • Bleeding or hemolysis as a cause of anemia
  • Deficiency of iron, folate and/or vitamin B12
  • Presence of chronic inflammatory disease or clinically significant infection
  • Hemoglobinopathies
  • Alcohol and/or drug abuse
  • Enrolment in another study
  • Any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures

Treatment and study plan

Primary outcomes

  1. existence of circadian rhythm of Erythropoietin and Melatonin

    Time frame: 24 hours

Secondary outcomes

  1. existence of a circadian rhythm of cortisol and IGF-1

    Time frame: 24 hours

  2. Relationship between temperature and melatonin. Relationship between blood pressure and erythropoietin

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Meander Medical Center

Other

Collaborators

  • Hoffmann-La Roche
  • Stichting Bijstand, Meander Medical Center

Registry information

Official study title

Circadian Rhythm of Erythropoietin and Melatonin in Patients With Various Degrees of Renal Insufficiency

Acronym: CREAM 1

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jun 17, 2008
Registry last updated
Jun 17, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.