Drug-Induced NephropathyPhase 2NCT02882373
Arginine in Treating Patients With Anti-VEGF Induced Kidney Injury
A Phase 2 study testing Arginine in people with Drug-Induced Nephropathy and Hypertension, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This phase II trial studies how well arginine works in treating patients with kidney injury caused by anti-VEGF drugs used in standard treatment for cancer. Arginine is a nutritional supplement that may control side effects of anti-cancer drugs such as high blood pressure and protein in the urine and may also help to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug-Induced Nephropathy, Hypertension, Proteinuria
- What is being tested?
- Arginine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2018to 15 May 2019
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- On or enrolled for anti-VEGF therapy
- Systolic Blood Pressure >= 140 mm Hg
- Diastolic Blood Pressure >= 90 mm Hg
- Proteinuria >= 500 mg/day or worsening glomerular filtration rate (GFR) (> 0.3 mg/dl in 48 hours [hrs.] or > 50% decline from baseline creatinine in 1 week)
Who cannot join
- Allergy to L-arginine
- Systolic Blood Pressure < 140 mm Hg
- Diastolic Blood Pressure < 90 mm Hg
- Proteinuria < 500 mg/day
- Continuous tube feeds (since the medication will be given in-between meals)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: L-Arginine For Anti-VEGF Induced Kidney Injury
This phase II trial studies how well arginine works in treating patients with kidney injury caused by anti-VEGF drugs used in standard treatment for cancer. Arginine is a nutritional supplement that may control side effects of anti-cancer drugs such as high blood pressure and protein in the urine and may also help to improve kidney function in patients.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess the value and/or limitations of using orally supplemented arginine (L-arginine) to improve renal function associated with the use of anti-angiogenic therapies that target vascular endothelial growth factor (VEGF).
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive arginine orally (PO) four times daily (QID). Treatment continues for up to 3 months in the absence of disease progression or unacceptable toxicity.
GROUP II: Patience receive placebo PO QID. Treatment continues for up to 3 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment patients are followed up within 1 month.
- Conditions
- Drug-Induced Nephropathy, Hypertension, Proteinuria
- Being tested
- Arginine, Placebo
- Medical subject headings
- Hypertension, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArginineDietary supplement
Also called Amino-5-guanidino-pentanoic acid, Arg, L-Arginine
Given PO
PlaceboDrug
Also called placebo therapy, PLCB, sham therapy
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Group I (arginine) | Experimental | Patients receive arginine PO QID. Treatment continues for up to 3 months in the absence of disease progression or unacceptable toxicity. Receives: Dietary Supplement: Arginine |
| Group II (placebo) | Placebo comparator | Patience receive placebo PO QID. Treatment continues for up to 3 months in the absence of disease progression or unacceptable toxicity. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in proteinuria as measured by protein-creatinine ratio (UPC) > 500 mg/day
Linear mixed effects regression will be utilized to analyze the longitudinal change of UPC between treatment and placebo groups.
Measured: Baseline up to 3 months
Secondary outcomes (2)
Improved glomerular filtration rate (GFR) >= 25%
Linear mixed effects regression will be utilized to analyze the GFR between treatment and placebo groups.
Measured: Baseline up to 3 months
Reduction in systolic blood pressure (SBP) >= 10 mmHg and/or diastolic blood pressure >= 5 mmHg
Linear mixed effects regression will be utilized to analyze the SBP between treatment and placebo groups.
Measured: Baseline up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2016 (estimated)
- Study start23 Oct 2018
- Primary completion15 May 2019
- Study completion15 May 2019
Why it stopped: Principal Investigator's Request
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug-Induced NephropathyStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Farhad Danesh, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02882373
- Sponsor's protocol ID
- 2015-1105
- Other IDs
- NCI-2018-02537, 2015-1105, P30CA016672
- Status last verified
- May 2019
- First submitted
- 22 Aug 2016
- Last updated
- 21 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- L-Arginine For Anti-VEGF Induced Kidney Injury
- ClinicalTrials.gov ID
- NCT02882373
- Acronym / sponsor ID
- 2015-1105
- Conditions
- Drug-Induced Nephropathy, Hypertension, Proteinuria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Principal Investigator's Request
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 23 Oct 2018 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 15 May 2019 (actual)
- First posted
- 29 Aug 2016 (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.
This phase II trial studies how well arginine works in treating patients with kidney injury caused by anti-VEGF drugs used in standard treatment for cancer. Arginine is a nutritional supplement that may control side effects of anti-cancer drugs such as high blood pressure and protein in the urine and may also help to improve kidney function in patients.
Detailed description
PRIMARY OBJECTIVES:
- To assess the value and/or limitations of using orally supplemented arginine (L-arginine) to improve renal function associated with the use of anti-angiogenic therapies that target vascular endothelial growth factor (VEGF).
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive arginine orally (PO) four times daily (QID). Treatment continues for up to 3 months in the absence of disease progression or unacceptable toxicity.
GROUP II: Patience receive placebo PO QID. Treatment continues for up to 3 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment patients are followed up within 1 month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (arginine) | Experimental | Dietary Supplement: ArgininePatients receive arginine PO QID. Treatment continues for up to 3 months in the absence of disease progression or unacceptable toxicity. |
| Group II (placebo) | Placebo comparator | Drug: PlaceboPatience receive placebo PO QID. Treatment continues for up to 3 months in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- On or enrolled for anti-VEGF therapy
- Systolic Blood Pressure >= 140 mm Hg
- Diastolic Blood Pressure >= 90 mm Hg
- Proteinuria >= 500 mg/day or worsening glomerular filtration rate (GFR) (> 0.3 mg/dl in 48 hours [hrs.] or > 50% decline from baseline creatinine in 1 week)
Key exclusion criteria (5 listed)
- Allergy to L-arginine
- Systolic Blood Pressure < 140 mm Hg
- Diastolic Blood Pressure < 90 mm Hg
- Proteinuria < 500 mg/day
- Continuous tube feeds (since the medication will be given in-between meals)
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 |
|---|---|---|
| ArginineAlso: Amino-5-guanidino-pentanoic acid, Arg, L-ArginineGiven PO | Dietary supplement | Group I (arginine) |
| PlaceboAlso: placebo therapy, PLCB, sham therapyGiven PO | Drug | Group II (placebo) |
Primary outcome
Reduction in proteinuria as measured by protein-creatinine ratio (UPC) > 500 mg/day
Time frame: Baseline up to 3 months
Linear mixed effects regression will be utilized to analyze the longitudinal change of UPC between treatment and placebo groups.
2 secondary outcomes
Improved glomerular filtration rate (GFR) >= 25%
Time frame: Baseline up to 3 months
Reduction in systolic blood pressure (SBP) >= 10 mmHg and/or diastolic blood pressure >= 5 mmHg
Time frame: Baseline up to 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2019.
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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.
Farhad Danesh principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Arginine in people with Drug-Induced Nephropathy and Hypertension, run by M.D. Anderson Cancer Center at 1 site in United States.
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 5 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: withdrawn, as of the sponsor's last update on 21 May 2019. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Reduction in proteinuria as measured by protein-creatinine ratio (UPC) > 500 mg/day (time frame: Baseline up to 3 months). 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 21 May 2019.