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Dextromethorphan and Silymarin in Chronic Kidney Disease (CKD) Patients (CKD)

Primary Purpose

Proteinuria

Status
Unknown status
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
Dextromethorphan
Silymarin
sugar pill
Sponsored by
National Cheng-Kung University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Proteinuria focused on measuring CKD, proteinuria, dextromethorphan, silymarin, patients with 15 ml<eGFR< 60ml and 0.5 g/day<proteinuria<3g/day

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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.
  2. Age between 18 and 75 years old.
  3. Patients without hospitalization for cardiac or infection related morbidity over the previous 2 months(due to the potential confounding effects on baseline study variables).
  4. Patients who are able to provide consent to participate in the study.-

Exclusion Criteria:

  1. patients will significant mental illness, pregnant women, and other vulnerable populations.
  2. Patients with active hepatic disease and/or ALT > 2.5 times upper limit of normal.
  3. Patients with history of congestive heart failure and NYHA Class III-IV symptoms at any time.
  4. 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.
  5. Patients with severe co-morbid conditions (eg, symptomatic hepatic cirrhosis, metastatic cancer, HIV infection with AIDS).
  6. Patient with active inflammatory process (eg., SLE, rheumatoid arthritis, gout) for which they are currently receiving immune modulating medications.
  7. Patients who are on corticosteroid therapy.
  8. Patients who do not consent to participate in the study.

Sites / Locations

  • National Cheng-Kung University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Dextromethorphan

Silymarin

sugar pill

Arm Description

Outcomes

Primary Outcome Measures

change of eGFR
Use MDRD-simplified equation
Change of Urine TP/Cr
Change of serum hsCRP
Change of urine TGF-beta/Cr level
fibrotic marker of kidney
Endothelial function
by Flow-mediated dilatation mesured by Crdiovascular ultrasound

Secondary Outcome Measures

Leukocyte ROCK activity
Measure leukocyte Ro kinase activity by western blotting This is an indicator of cardiovascular function
Blood MDA level
Indicator of oxidative stress
Blood TGF-beta
By Elisa
Urine MCP-1/Cr level

Full Information

First Posted
February 9, 2010
Last Updated
March 22, 2010
Sponsor
National Cheng-Kung University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01091324
Brief Title
Dextromethorphan and Silymarin in Chronic Kidney Disease (CKD) Patients
Acronym
CKD
Official Title
The Reno-protective and Cardiovascular Effect of Dextromethorphan and Silymarin in Patients With Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
June 2010 (Anticipated)
Study Completion Date
July 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
National Cheng-Kung University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proteinuria
Keywords
CKD, proteinuria, dextromethorphan, silymarin, patients with 15 ml<eGFR< 60ml and 0.5 g/day<proteinuria<3g/day

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dextromethorphan
Arm Type
Active Comparator
Arm Title
Silymarin
Arm Type
Active Comparator
Arm Title
sugar pill
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Dextromethorphan
Intervention Description
60 mg, bid
Intervention Type
Drug
Intervention Name(s)
Silymarin
Intervention Description
150 mg , tid
Intervention Type
Drug
Intervention Name(s)
sugar pill
Intervention Description
placebo
Primary Outcome Measure Information:
Title
change of eGFR
Description
Use MDRD-simplified equation
Time Frame
4 months
Title
Change of Urine TP/Cr
Time Frame
4 months
Title
Change of serum hsCRP
Time Frame
4 months
Title
Change of urine TGF-beta/Cr level
Description
fibrotic marker of kidney
Time Frame
4 months
Title
Endothelial function
Description
by Flow-mediated dilatation mesured by Crdiovascular ultrasound
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Leukocyte ROCK activity
Description
Measure leukocyte Ro kinase activity by western blotting This is an indicator of cardiovascular function
Time Frame
4 months
Title
Blood MDA level
Description
Indicator of oxidative stress
Time Frame
4 months
Title
Blood TGF-beta
Description
By Elisa
Time Frame
4 months
Title
Urine MCP-1/Cr level
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junne-Ming Sung, MD
Organizational Affiliation
National Cheng-Kung University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cheng-Kung University Hospital
City
Taian
Country
Taiwan

12. IPD Sharing Statement

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Dextromethorphan and Silymarin in Chronic Kidney Disease (CKD) Patients

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