NCT01091324

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2010

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 9, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 24, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

March 24, 2010

Status Verified

March 1, 2010

Enrollment Period

5 months

First QC Date

February 9, 2010

Last Update Submit

March 22, 2010

Conditions

Proteinuria

Keywords

CKD, proteinuria, dextromethorphan, silymarinpatients with 15 ml<eGFR< 60ml and 0.5 g/day<proteinuria<3g/day

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (4)

  • Leukocyte ROCK activity

    4 months

  • Blood MDA level

    4 months

  • Blood TGF-beta

    4 months

  • Urine MCP-1/Cr level

    4 months

Study Arms (3)

Dextromethorphan

ACTIVE COMPARATOR
Drug: Dextromethorphan

Silymarin

ACTIVE COMPARATOR
Drug: Silymarin

sugar pill

PLACEBO COMPARATOR
Drug: sugar pill

Interventions

DextromethorphanDRUG

60 mg, bid

Dextromethorphan
SilymarinDRUG

150 mg , tid

Silymarin
sugar pillDRUG

placebo

sugar pill

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Age between 18 and 75 years old.
  • Patients without hospitalization for cardiac or infection related morbidity over the previous 2 months(due to the potential confounding effects on baseline study variables).
  • Patients who are able to provide consent to participate in the study.-

You may not qualify if:

  • patients will significant mental illness, pregnant women, and other vulnerable populations.
  • Patients with active hepatic disease and/or ALT \> 2.5 times upper limit of normal.
  • Patients with history of congestive heart failure and NYHA Class III-IV symptoms at any time.
  • 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.
  • Patients with severe co-morbid conditions (eg, symptomatic hepatic cirrhosis, metastatic cancer, HIV infection with AIDS).
  • Patient with active inflammatory process (eg., SLE, rheumatoid arthritis, gout) for which they are currently receiving immune modulating medications.
  • Patients who are on corticosteroid therapy.
  • Patients who do not consent to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cheng-Kung University Hospital

Taian, Taiwan, Taiwan

Location

MeSH Terms

Conditions

Proteinuria

Interventions

DextromethorphanSilymarinSugars

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsFlavonolignansFlavonoidsChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic Compounds, 2-RingCarbohydrates

Study Officials

  • Junne-Ming Sung, MD

    National Cheng-Kung University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 9, 2010

First Posted

March 24, 2010

Study Start

January 1, 2010

Primary Completion

June 1, 2010

Study Completion

July 1, 2010

Last Updated

March 24, 2010

Record last verified: 2010-03

Locations

TW(1)