Dextromethorphan and Silymarin in Chronic Kidney Disease (CKD) Patients

Phase 3

• Conditions: Proteinuria
• Interventions: Drug: Silymarin; Drug: sugar pill; Drug: Dextromethorphan

• Registration Number: NCT01091324
• Lead Sponsor: National Cheng-Kung University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-02-09
• Status Verified: 2010-03
• Study First Submitted QC: 2010-03-22
• Last Update Submitted: 2010-03-22
• Study First Posted: 2010-03-24
• Last Update Posted: 2010-03-24
• Primary Completion: 2010-06
• Study Completion: 2010-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Silymarin	Silymarin	-
sugar pill	sugar pill	-
Dextromethorphan	Dextromethorphan	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

National Cheng-Kung University Hospital; 🇨🇳 Taian, Taiwan