Clinical trial NCT01091324: Dextromethorphan and Silymarin in Chronic Kidney Disease (CKD) Patients
Official title: The Reno-protective and Cardiovascular Effect of Dextromethorphan and Silymarin in Patients With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Proteinuria
Keywords: CKD, proteinuria, dextromethorphan, silymarin
patients with 15 ml<eGFR< 60ml and 0.5 g/day<proteinuria<3g/day
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2010-03-24
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: change of eGFR
timeFrame: 4 months
measure: Change of Urine TP/Cr
timeFrame: 4 months
measure: Change of serum hsCRP
timeFrame: 4 months
measure: Change of urine TGF-beta/Cr level
timeFrame: 4 months
measure: Endothelial function
timeFrame: 4 months
Secondary outcomes:
measure: Leukocyte ROCK activity
timeFrame: 4 months
measure: Blood MDA level
timeFrame: 4 months
measure: Blood TGF-beta
timeFrame: 4 months
measure: Urine MCP-1/Cr level
timeFrame: 4 months
Other outcomes:
Locations:
city: Taian
country: Taiwan
facility: National Cheng-Kung University Hospital
Study officials:
affiliation: National Cheng-Kung University Hospital
name: Junne-Ming Sung, MD
role: PRINCIPAL_INVESTIGATOR
References: