This trial is active, not recruiting.

Condition proteinuria
Treatments dextromethorphan, silymarin, sugar pill
Phase phase 3
Sponsor National Cheng-Kung University Hospital
Start date January 2010
End date June 2010
Trial size 45 participants
Trial identifier NCT01091324, HR-97-108


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
(Active Comparator)
60 mg, bid
(Active Comparator)
150 mg , tid
(Placebo Comparator)
sugar pill

Primary Outcomes

change of eGFR
time frame: 4 months
Change of Urine TP/Cr
time frame: 4 months
Change of serum hsCRP
time frame: 4 months
Change of urine TGF-beta/Cr level
time frame: 4 months
Endothelial function
time frame: 4 months

Secondary Outcomes

Leukocyte ROCK activity
time frame: 4 months
Blood MDA level
time frame: 4 months
Blood TGF-beta
time frame: 4 months
Urine MCP-1/Cr level
time frame: 4 months

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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 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.

Additional Information

Official title The Reno-protective and Cardiovascular Effect of Dextromethorphan and Silymarin in Patients With Chronic Kidney Disease
Principal investigator Junne-Ming Sung, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2010.
Information provided to ClinicalTrials.gov by National Cheng-Kung University Hospital.