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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
  Purpose

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 Intervention Phase
Proteinuria
 Drug: Dextromethorphan
Drug: Silymarin
Drug: sugar pill
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Reno-protective and Cardiovascular Effect of Dextromethorphan and Silymarin in Patients With Chronic Kidney Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cheng-Kung University Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 45
Study Start Date: January 2010
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dextromethorphan Drug: Dextromethorphan
60 mg, bid
Active Comparator: Silymarin Drug: Silymarin
150 mg , tid
Placebo Comparator: sugar pill Drug: sugar pill
placebo

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: February 9, 2010
Last Updated: March 22, 2010
Health Authority: Taiwan: National Bureau of Controlled Drugs

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
Proteinuria
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Urination Disorders
Urological Manifestations
Signs and Symptoms
Renal Insufficiency
Dextromethorphan
Silymarin
Excitatory Amino Acid Antagonists
 Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antitussive Agents
Central Nervous System Agents
Therapeutic Uses
Respiratory System Agents
Antioxidants
Protective Agents

ClinicalTrials.gov processed this record on June 18, 2013