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CompletedNCT00356733Updated Dec 2, 2011

Mechanisms of Erythropoietin Action in the Cardiorenal Syndrome

A Phase 3 interventional study of Erythropoietin administration in Heart Failure, Congestive and Renal Insufficiency, Chronic, sponsored by UMC Utrecht. Completed at 2 sites in Netherlands. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2011-12-02.

Sponsored by UMC Utrecht · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Erythropoietin (EPO) treatment in patients with the severe cardiorenal syndrome increases cardiac performance and decreases progression of renal failure by dampening the main driving forces of the cardiorenal syndrome in part via non-erythropoietic pathways.

I. Does EPO administration to patients with the severe cardiorenal syndrome increase cardiac performance and decrease progression of renal disease?

II. Does EPO treatment affect the main driving forces of the cardiorenal connection, that is, dampen the activated renin-angiotensin system (RAS), attenuate increased reactive oxygen species (ROS), normalize increased sympathetic activity, and decrease inflammation?

III. Does EPO treatment positively affect the cell function of patients with the cardiorenal syndrome:

  1. are gene expression signatures of leukocytes positively influenced by EPO treatment,
  2. does EPO shift the Jak/STAT pathway to a less pro-inflammatory profile in monocytes, and
  3. are function and number of endothelial progenitor cells (EPCs) affected by treatment with EPO in the cardiorenal syndrome?

IV. Can the direct actions of EPO be differentiated from the effects on hemoglobin levels?

Read the detailed description

The combination of renal and cardiac failure is associated with an extraordinary cardiovascular morbidity and mortality. We propose that the severe cardiorenal syndrome (SCRS), the pathophysiological condition in which there is combined cardiac and renal dysfunction, amplifies the progression of the failure of the individual organ. Central in the pathogenesis of the cardiorenal syndrome is enhanced oxidative stress, inflammation and enhanced activation of the renin-angiotensin and sympathetic nervous system. Chronic renal failure is further accompanied by anemia due to a gradual decline in erythropoietin (EPO) formation by the diseased kidneys and/or by EPO resistance. Recently, the interest in EPO is increasing since it serves not only as a hematopoietic factor, but also has been shown to increase the number of endothelial progenitor cells (EPCs) in end-stage renal disease (ESRD) patients. Moreover, EPO is involved in signaling via Akt to support NO release and may act as an anti-apoptotic. Some evidence supports the idea that EPO improves cardiac and renal function in the syndrome; however, no information is available about the mechanisms. The hypothesis of the present proposal is that EPO treatment in patients with the severe cardiorenal syndrome increases cardiac performance and decreases progression of renal failure in part via non-erythropoietic pathways. The questions are whether EPO administration to patients with the severe cardiorenal syndrome:

  1. increases cardiac performance and decreases progression of renal disease,
  2. dampens the activated RAS and sympathetic nervous system, attenuates increased ROS and decreases signs of inflammation and
  3. positively influences cell function of leukocytes (assessed by gene expression signatures), of monocytes (shifts to a less pro-inflammatory Jak/Stat signaling) and of EPC (number and function).

This will be addressed in a two-part clinical study in patients with combined moderate chronic renal failure and heart failure (New York Heart Association [NYHA] II-III). First, patients will be treated with EPO for 12 months, and hemoglobin levels will be kept constant at initial levels or will be allowed to increase; another group will be left untreated. Besides cardiac and renal function, the RAS, the SNS, and ROS/NOS balance and inflammatory parameters will be assessed. Furthermore, cell function of leukocytes (gene expression signatures), monocytes (Jak/STAT activation) and EPCs (number and function) will be studied. Taken together, central in the proposal is that combined heart-kidney failure is accompanied by relative or absolute EPO dysfunction, disproportional to the degree of renal failure and that treatment with EPO improves cardiac performance and renal function.

02

Conditions studied

  • Heart Failure, Congestive
  • Renal Insufficiency, Chronic

Keywords

  • cardiorenal syndrome
  • erythropoietin
  • Heart Failure, Congestive
  • Renal Insufficiency, Chronic
03

In context

Heart Failure

5,803 studies on the registry are indexed under Heart Failure; 1,222 are open to participants now.

This study's enrollment of 62 is below the median of 72 across 3,790 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

UMC Utrecht is the lead sponsor of 363 studies on the registry; 81 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with moderate renal failure (glomerular filtration rate [GFR] by Cockroft formula of 20-70 ml/min)
  • Patients with heart failure NYHA class II-III-IV
  • Hemoglobin (Hb) between 6.4 - 7.8 mmol/L in men and between 6.0 - 7.4 mmol/L in women
  • Age > 18 years, \< 80 years
  • Written informed consent must be obtained from the subject or legally accepted representative before study-specific procedures, including screening procedures, are performed.

Exclusion criteria

Exclusion Criteria:

  • Therapy within 1 year before randomisation or any planned erythropoietic therapy between randomisation and study day 1
  • Known intolerance to EPO administration
  • Previously suspected of or confirmed to have neutralizing antibodies to recombinant human erythropoietin (rHuEPO)
  • Uncontrolled hypertension (RR > 160 systolic, >100 diastolic)
  • Forms of secondary hypertension other than renal hypertension
  • Uncontrolled diabetes (HbA1c > 8.0 %)
  • Primary dyslipidemia
  • Kidney transplantation
  • Proteinuria > 3.5 g/L
  • Acute renal failure or rapidly progressive glomerulonephritis
  • Hyperparathyroidism (parathyroid hormone [PTH] > 40)
  • Bleeding or haemolysis as a cause of anaemia
  • Deficiency of iron, folate, and/or vitamin B12
  • Presence of chronic inflammatory disease or clinically significant infection
  • Haematologic malignancy or solid tumour \< 5 years ago
  • Chronic liver disease
  • Haemoglobinopathies
  • Alcohol and/or drug abuse
  • Enrolment in another study
  • Child bearing potential (pre-menopausal woman who is not using adequate contraceptive precautions)
  • Any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
62 participants (actual)

Study arms

  • Experimental
    EPO rise

    EPO administration

    Drug: Erythropoietin administration

  • Experimental
    EPO stable

    EPO and stable Hemoglobin

    Drug: Erythropoietin administration

  • No intervention
    control

    standard treatment

Interventions

  • DrugErythropoietin administration

    50 IU/kg/week EPO to a target haemoglobin level of 13.7 g/dL for men and 13.4 g/dL for women (group A) or to a target comparable to starting hemoglobin level (group B)

06

What researchers measure

Primary outcomes

  1. changes in gene-arrays, EPC and biomarkers panels

    Time frame: 14 days, 6 and 12 months

Secondary outcomes

  1. cardiac performance and renal function

    Time frame: 6 and 12 months

  2. QoL

    Time frame: 6 and 12 months

07

Study locations

2 sites
  • Meander Medical Center Amersfoort
    Amersfoort, Utrecht 3800 BM, Netherlands
  • Univ. Medical Center Utrecht
    Utrecht, Utrecht 3508 GA, Netherlands
08

References and documents

Publications

  • Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3. PubMed 36791280 ↗
  • Eisenga MF, Emans ME, van der Putten K, Cramer MJ, Diepenbroek A, Velthuis BK, Doevendans PA, Verhaar MC, Joles JA, Bakker SJL, Nolte IM, Braam B, Gaillard CAJM. Epoetin Beta and C-Terminal Fibroblast Growth Factor 23 in Patients With Chronic Heart Failure and Chronic Kidney Disease. J Am Heart Assoc. 2019 Aug 20;8(16):e011130. doi: 10.1161/JAHA.118.011130. Epub 2019 Aug 17. PubMed 31423921 ↗
  • Emans ME, van der Putten K, Velthuis BK, de Vries JJ, Cramer MJ, America YG, Hillege HL, Meiss L, Doevendans PA, Braam B, Gaillard CA. Atherosclerotic renal artery stenosis is prevalent in cardiorenal patients but not associated with left ventricular function and myocardial fibrosis as assessed by cardiac magnetic resonance imaging. BMC Cardiovasc Disord. 2012 Sep 18;12:76. doi: 10.1186/1471-2261-12-76. PubMed 22989293 ↗
  • van der Putten K, Jie KE, Emans ME, Verhaar MC, Joles JA, Cramer MJ, Velthuis BK, Meiss L, Kraaijenhagen RJ, Doevendans PA, Braam B, Gaillard CA. Erythropoietin treatment in patients with combined heart and renal failure: objectives and design of the EPOCARES study. J Nephrol. 2010 Jul-Aug;23(4):363-8. PubMed 20383871 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00356733
Lead sponsor
UMC Utrecht
Collaborators
Dutch Heart Foundation
Responsible party
G.B. Braam (Associate Professor of Medicine, University of Alberta) — Principal investigator
First posted
Jul 26, 2006
Start date
Jan 2007
Primary completion
Jul 2011
Completion
Jul 2011
Last update
Dec 2, 2011

Study contacts

Branko Braam, MD, PhD
principal investigator · UMC Utrecht, The Netherlands
Carlo AJ Gaillard, MD, PhD
principal investigator · Meander Medical Center Amersfoort, The Netherlands
Pieter AF Doevendans, MD, PhD
study director · UMC Utrecht, The Netherlands
View the source record on ClinicalTrials.gov ↗

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