In this randomized, placebo-controlled study, we aim to investigate whether combination of PTX with standard treatment regimen results in additive reduction in proteinuria in patients with membranous nephropathy. Patients with biopsy proven membranous nephropathy are randomized into two groups. Group A receives standard treatment regimen plus pentoxifylline (1200 mg/day), whereas group B receives standard treatment regimen plus placebo. The treatment duration is 6 months for both subgroups. Glomerular filtration rates (GFR) calculated by Cockcroft-Gault formula and urine protein excretion by 24-hour urinary protein will be determined are measured at the baseline and two and six months after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138810273043N1
Registration date:2010-09-10, 1389/06/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-09-10, 1389/06/19
Registrant information
Name
Simin Dashti-Khavidaki
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 4709
Email address
dashtis@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciencies
Expected recruitment start date
2010-01-01, 1388/10/11
Expected recruitment end date
2013-01-01, 1391/10/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Pentoxifylline on Proteinuria in Patients with Membranous Nephropathy
Public title
Effect of Pentoxifylline on Proteinuria
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: New cases with biopsy proven Membranous Nephropathy, Initial Random urine protein (mg/dl) > 2 g/day based on 24-hr urine collection
Exclusion Criteria: Pregnancy, Breast feeding, Diabetes Mellitus, History of allergy to Pentoxifylline or any derivatives of methyl xanthenes, Cerebral hemorrhage or Retinal hemorrhage within the past 6 months prior to signing the informed consent form, Congestive heart failure (NYHA functional class III or IV), Uncontrolled hypertension (SBP > 200 mmHg and/or DBP > 110 mmHg), history of unstable angina, myocardial infarction, cerebrovascular accidents, Stroke, Obstructive uropathy, Cirrhosis, Hepatic dysfunction as defined by the following laboratory parameters: ALT or AST > 5 times the upper limit of the normal range, or > 3 times concomitant with signs and symptoms of hepatic failure
Age
From 14 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Efficacy study
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice-chancellor for Research
Street address
Tehran University of Medical Sciences
City
Tehran
Postal code
Approval date
2010-05-23, 1389/03/02
Ethics committee reference number
89-01-33-9694
Health conditions studied
1
Description of health condition studied
Membranous Nephropathy
ICD-10 code
N00, N01,
ICD-10 code description
Glomerular Diseases
Primary outcomes
1
Description
urinary protein excretion
Timepoint
2 and 6 months after study initiation
Method of measurement
Measurement of Urinary Protein Excretion based on 24-hr urine collection
Secondary outcomes
1
Description
Glomerular Filtration Rate (GFR)
Timepoint
2 and 6 months after study initiation
Method of measurement
GFR will be calculated by Cockcroft-Gault formula
Intervention groups
1
Description
standard treatment regimen + placebo (400 mg, three times/day, for 6 months)
Category
Placebo
2
Description
standard treatment regimen + pentoxifylline (400 mg, three times/day, for 6 months)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Dr. Simin Dashti Khavidaki
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciencies
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Simin Dashti Khavidaki
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciencies
City
Tehran
Grant name
-
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Simin Dashti Khavidaki
Position
Associate Professor
Other areas of specialty/work
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 6695 4709
Fax
Email
dashtis@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shirinsadat Badri
Position
Resident of Clinical Pharmacy
Other areas of specialty/work
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 6695 4709
Fax
Email
sh.s.badri@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)