Condition category
Urological and Genital Diseases
Date applied
07/08/2005
Date assigned
11/08/2005
Last edited
25/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Hamid Tayebi Khosroshahi

ORCID ID

Contact details

Dialysis Center
Imam Hospital
Daneshgah Street
Tabriz
Iran
+98 411 3344339
drtayebikh@yahoo.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Carnitine-Epo

Study hypothesis

Anemia in chronic haemodialysis patients is improved by administration of Erythropoietin or L-Carnitine or Erythropoietin plus L-Carnitine.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Chronic Renal Failure (End-Stage Renal Disease [ESRD])

Intervention

1. Administration of rHu-EPO 4000 IU/week, subcutaneously (SC) (2000 IU, twice weekly) for 3 months (N = 20)
2. Administration of L-Carnitine 500 mg/day, orally, for 3 months (N = 15)
3. Administration of rHu-EPO 4000 IU/week, SC PLUS L-Carnitine 500 mg/day, orally, for 3 months (N = 15)

Intervention type

Drug

Phase

Not Specified

Drug names

Erythropoietin, L-Carnitine

Primary outcome measures

Haemoglobin level

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/03/2003

Overall trial end date

01/03/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Dialysis for more than 6 months
2. Hb less than 11 g/dl

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. Active infectious disease
2. Active bleeding disorders

Recruitment start date

01/03/2003

Recruitment end date

01/03/2005

Locations

Countries of recruitment

Iran

Trial participating centre

Dialysis Center
Tabriz
Iran

Sponsor information

Organisation

Tabriz University of Medical Sciences (Iran)

Sponsor details

Daneshgah Street
Tabriz
Iran

Sponsor type

University/education

Website

http://www.tbzmed.ac.ir

Funders

Funder type

University/education

Funder name

Tabriz University of Medical Sciences (Iran)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes