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

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ClinicalTrials.gov Identifier: NCT01091324
Recruitment Status : Unknown
Verified March 2010 by National Cheng-Kung University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : March 24, 2010
Last Update Posted : March 24, 2010
Sponsor:
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Proteinuria Drug: Dextromethorphan Drug: Silymarin Drug: sugar pill Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Reno-protective and Cardiovascular Effect of Dextromethorphan and Silymarin in Patients With Chronic Kidney Disease
Study Start Date : January 2010
Estimated Primary Completion Date : June 2010
Estimated Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Dextromethorphan Drug: Dextromethorphan
60 mg, bid
Active Comparator: Silymarin Drug: Silymarin
150 mg , tid
Placebo Comparator: sugar pill Drug: sugar pill
placebo


Outcome Measures

Primary Outcome Measures :
  1. change of eGFR [ Time Frame: 4 months ]
    Use MDRD-simplified equation

  2. Change of Urine TP/Cr [ Time Frame: 4 months ]
  3. Change of serum hsCRP [ Time Frame: 4 months ]
  4. Change of urine TGF-beta/Cr level [ Time Frame: 4 months ]
    fibrotic marker of kidney

  5. Endothelial function [ Time Frame: 4 months ]
    by Flow-mediated dilatation mesured by Crdiovascular ultrasound


Secondary Outcome Measures :
  1. Leukocyte ROCK activity [ Time Frame: 4 months ]
    Measure leukocyte Ro kinase activity by western blotting This is an indicator of cardiovascular function

  2. Blood MDA level [ Time Frame: 4 months ]
    Indicator of oxidative stress

  3. Blood TGF-beta [ Time Frame: 4 months ]
    By Elisa

  4. Urine MCP-1/Cr level [ Time Frame: 4 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01091324


Locations
Taiwan
National Cheng-Kung University Hospital
Taian, Taiwan
Sponsors and Collaborators
National Cheng-Kung University Hospital
Investigators
Principal Investigator: Junne-Ming Sung, MD National Cheng-Kung University Hospital
More Information

Responsible Party: Junne-Ming Sung, National Cheng Kung University Hospital (NCKUH)
ClinicalTrials.gov Identifier: NCT01091324     History of Changes
Other Study ID Numbers: HR-97-108
First Posted: March 24, 2010    Key Record Dates
Last Update Posted: March 24, 2010
Last Verified: March 2010

Keywords provided by National Cheng-Kung University Hospital:
CKD, proteinuria, dextromethorphan, silymarin
patients with 15 ml<eGFR< 60ml and 0.5 g/day<proteinuria<3g/day

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Proteinuria
Urologic Diseases
Renal Insufficiency
Urination Disorders
Urological Manifestations
Signs and Symptoms
Dextromethorphan
Silymarin
Antitussive Agents
Respiratory System Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antioxidants
Protective Agents