Dextromethorphan and Silymarin in Chronic Kidney Disease (CKD) Patients

Proteinuria Clinical Trial

— CKD  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01091324
• Other study ID #: HR-97-108
• Status: Active, not recruiting
• Phase: Phase 3
• First received: February 9, 2010
• Last updated: March 22, 2010
• Start date: January 2010
• Est. completion date: July 2010

Study information

• Verified date: March 2010
• Source: National Cheng-Kung University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: National Bureau of Controlled Drugs
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: July 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Kidney Diseases
• Proteinuria
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
Taiwan	National Cheng-Kung University Hospital	Taian

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of eGFR	Use MDRD-simplified equation	4 months	No
Primary	Change of Urine TP/Cr		4 months	No
Primary	Change of serum hsCRP		4 months	No
Primary	Change of urine TGF-beta/Cr level	fibrotic marker of kidney	4 months	No
Primary	Endothelial function	by Flow-mediated dilatation mesured by Crdiovascular ultrasound	4 months	No
Secondary	Leukocyte ROCK activity	Measure leukocyte Ro kinase activity by western blotting This is an indicator of cardiovascular function	4 months	No
Secondary	Blood MDA level	Indicator of oxidative stress	4 months	No
Secondary	Blood TGF-beta	By Elisa	4 months	No
Secondary	Urine MCP-1/Cr level		4 months	No