ProteinuriaPhase 3CKDNCT01091324
Dextromethorphan and Silymarin in Chronic Kidney Disease (CKD) Patients
A Phase 3 study testing Dextromethorphan, Silymarin and sugar pill in people with Proteinuria, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Proteinuria
- What is being tested?
- Dextromethorphan, Silymarin and sugar pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2010to Jul 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.-
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Reno-protective and Cardiovascular Effect of Dextromethorphan and Silymarin in Patients With Chronic Kidney Disease
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.
- Conditions
- Proteinuria
- Being tested
- Dextromethorphan, Silymarin, sugar pill
- Keywords
- CKD, proteinuria, dextromethorphan, silymarin, patients with 15 ml<eGFR< 60ml and 0.5 g/day<proteinuria<3g/day
- Medical subject headings
- Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DextromethorphanDrug
60 mg, bid
SilymarinDrug
150 mg , tid
sugar pillDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Dextromethorphan | Active comparator | Not described Receives: Drug: Dextromethorphan |
| Silymarin | Active comparator | Not described Receives: Drug: Silymarin |
| sugar pill | Placebo comparator | Not described Receives: Drug: sugar pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of eGFR
Use MDRD-simplified equation
Measured: 4 months
Change of Urine TP/Cr
Measured: 4 months
Change of serum hsCRP
Measured: 4 months
Change of urine TGF-beta/Cr level
fibrotic marker of kidney
Measured: 4 months
Endothelial function
by Flow-mediated dilatation mesured by Crdiovascular ultrasound
Measured: 4 months
Secondary outcomes (4)
Leukocyte ROCK activity
Measure leukocyte Ro kinase activity by western blotting This is an indicator of cardiovascular function
Measured: 4 months
Blood MDA level
Indicator of oxidative stress
Measured: 4 months
Blood TGF-beta
By Elisa
Measured: 4 months
Urine MCP-1/Cr level
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2010 (estimated)
- Study startJan 2010
- Primary completionJun 2010 (estimated)
- Study completionJul 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProteinuriaStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Junne-Ming Sung, MD, Principal investigator, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01091324
- Sponsor's protocol ID
- HR-97-108
- Acronym
- CKD
- Status last verified
- Mar 2010
- First submitted
- 9 Feb 2010
- Last updated
- 24 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Reno-protective and Cardiovascular Effect of Dextromethorphan and Silymarin in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT01091324
- Acronym / sponsor ID
- CKD / HR-97-108
- Conditions
- Proteinuria
- Keywords
- CKD, proteinuria, dextromethorphan, silymarin, patients with 15 ml<eGFR< 60ml and 0.5 g/day<proteinuria<3g/day
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Jul 2010 (estimated)
- First posted
- 24 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dextromethorphan | Active comparator | Drug: Dextromethorphan |
| Silymarin | Active comparator | Drug: Silymarin |
| sugar pill | Placebo comparator | Drug: sugar pill |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.-
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dextromethorphan60 mg, bid | Drug | Dextromethorphan |
| Silymarin150 mg , tid | Drug | Silymarin |
| sugar pillplacebo | Drug | sugar pill |
Primary outcome
change of eGFR
Time frame: 4 months
Use MDRD-simplified equation
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
fibrotic marker of kidney
Endothelial function
Time frame: 4 months
by Flow-mediated dilatation mesured by Crdiovascular ultrasound
4 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junne-Ming Sung, MD principal investigator
National Cheng-Kung University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dextromethorphan, Silymarin and sugar pill in people with Proteinuria, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of eGFR (time frame: 4 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2010.