Dextromethorphan and Silymarin in Chronic Kidney Disease (CKD) Patients

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2010 by National Cheng-Kung University Hospital.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

National Cheng-Kung University Hospital

ClinicalTrials.gov Identifier:

NCT01091324

First received: February 9, 2010

Last updated: March 22, 2010

Last verified: March 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

February 9, 2010

Last Updated Date

March 22, 2010

Start Date ^ICMJE

January 2010

Estimated Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

change of eGFR [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Use MDRD-simplified equation
Change of Urine TP/Cr [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Change of serum hsCRP [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Change of urine TGF-beta/Cr level [ Time Frame: 4 months ] [ Designated as safety issue: No ]
fibrotic marker of kidney
Endothelial function [ Time Frame: 4 months ] [ Designated as safety issue: No ]
by Flow-mediated dilatation mesured by Crdiovascular ultrasound

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01091324 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Leukocyte ROCK activity [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Measure leukocyte Ro kinase activity by western blotting This is an indicator of cardiovascular function
Blood MDA level [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Indicator of oxidative stress
Blood TGF-beta [ Time Frame: 4 months ] [ Designated as safety issue: No ]
By Elisa
Urine MCP-1/Cr level [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Dextromethorphan and Silymarin in Chronic Kidney Disease (CKD) Patients

Official Title ^ICMJE

The Reno-protective and Cardiovascular Effect of Dextromethorphan and Silymarin in Patients With Chronic Kidney Disease

Brief Summary

The investigators test the renal and cardiovascular protective effects dextromethorphan and silymarin on patients with the proteinuric chronic kidney diseases, who enrolled in our clinical trial, had progressing kidney diseases and merit aggressive anti-inflammatory therapy.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Proteinuria

Intervention ^ICMJE

Drug: Dextromethorphan
60 mg, bid
Drug: Silymarin
150 mg , tid
Drug: sugar pill
placebo

Study Arm (s)

Active Comparator: Dextromethorphan
Intervention: Drug: Dextromethorphan
Active Comparator: Silymarin
Intervention: Drug: Silymarin
Placebo Comparator: sugar pill
Intervention: Drug: sugar pill

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2010

Estimated Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients with Stage 3 or 4 chronic kidney disease as measured by a Modification in Diet in Renal Disease Study (MDRD) estimate of between 15 ml/min and 59 ml/min and and 0.5 g/day<proteinuria<3g/day.
Age between 18 and 75 years old.
Patients without hospitalization for cardiac or infection related morbidity over the previous 2 months(due to the potential confounding effects on baseline study variables).
Patients who are able to provide consent to participate in the study.-

Exclusion Criteria:

patients will significant mental illness, pregnant women, and other vulnerable populations.
Patients with active hepatic disease and/or ALT > 2.5 times upper limit of normal.
Patients with history of congestive heart failure and NYHA Class III-IV symptoms at any time.
Patients for whom living donor renal transplantation is already scheduled or in the process of being evaluated, as these patients will be unlikely to complete study protocols before transplantation.
Patients with severe co-morbid conditions (eg, symptomatic hepatic cirrhosis, metastatic cancer, HIV infection with AIDS).
Patient with active inflammatory process (eg., SLE, rheumatoid arthritis, gout) for which they are currently receiving immune modulating medications.
Patients who are on corticosteroid therapy.
Patients who do not consent to participate in the study.

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Taiwan

Administrative Information

NCT Number ^ICMJE

NCT01091324

Other Study ID Numbers ^ICMJE

HR-97-108

Has Data Monitoring Committee

Yes

Responsible Party

Junne-Ming Sung, National Cheng Kung University Hospital (NCKUH)

Study Sponsor ^ICMJE

National Cheng-Kung University Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Junne-Ming Sung, MD

National Cheng-Kung University Hospital

Information Provided By

National Cheng-Kung University Hospital

Verification Date

March 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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