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

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

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.

Study Overview

• Status: Unknown
• Conditions: Proteinuria
• Intervention / Treatment: Drug: Dextromethorphan; Drug: Silymarin; Drug: sugar pill

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Phase 3

Contacts and Locations

Study Locations

• Taiwan
  • Taian, Taiwan
    • National Cheng-Kung University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: sugar pill	Drug: sugar pill; placebo
Active Comparator: Dextromethorphan	Drug: Dextromethorphan; 60 mg, bid
Active Comparator: Silymarin	Drug: Silymarin; 150 mg , tid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of eGFR	Use MDRD-simplified equation	4 months
Change of Urine TP/Cr		4 months
Change of serum hsCRP		4 months
Change of urine TGF-beta/Cr level	fibrotic marker of kidney	4 months
Endothelial function	by Flow-mediated dilatation mesured by Crdiovascular ultrasound	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Leukocyte ROCK activity	Measure leukocyte Ro kinase activity by western blotting This is an indicator of cardiovascular function	4 months
Blood MDA level	Indicator of oxidative stress	4 months
Blood TGF-beta	By Elisa	4 months
Urine MCP-1/Cr level		4 months

Collaborators and Investigators

• Sponsor: National Cheng-Kung University Hospital
• Investigators: Principal Investigator: Junne-Ming Sung, MD, National Cheng-Kung University Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Anticipated): June 1, 2010
• Study Completion (Anticipated): July 1, 2010

Study Registration Dates

• First Submitted: February 9, 2010
• First Submitted That Met QC Criteria: March 22, 2010
• First Posted (Estimate): March 24, 2010

Study Record Updates

• Last Update Posted (Estimate): March 24, 2010
• Last Update Submitted That Met QC Criteria: March 22, 2010
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: CKD, proteinuria, dextromethorphan, silymarin; patients with 15 ml<eGFR< 60ml and 0.5 g/day<proteinuria<3g/day
• Additional Relevant MeSH Terms: Urologic Diseases; Urological Manifestations; Renal Insufficiency; Urination Disorders; Kidney Diseases; Renal Insufficiency, Chronic; Proteinuria; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Protective Agents; Respiratory System Agents; Antioxidants; Antitussive Agents; Dextromethorphan; Silymarin
• Other Study ID Numbers: HR-97-108