Acute Kidney InjuryPhase 2NCT04496596
Study of Suramin in Subjects With Furosemide-Resistant AKI
A Phase 2 study testing Suramin in people with Acute Kidney Injury, run by Rediscovery Life Sciences at 12 sites in United States.
Trial summary
This is a prospective, double-blind, randomized, placebo-controlled study to assess the effects of suramin as a potential treatment option to prevent subjects with AKI from progressing to Kidney Disease Improving Global Outcomes (KDIGO) Stage III or dialysis dependent AKI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Suramin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 12 sitesUnited States
- Study dates
- 13 Nov 2020to 22 Dec 2023
- 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
- At least 18 years of age at the time of signing the informed consent
- KDIGO Stage I AKI and a serum Cr increase ≥ 0.3 mg/dL within 48 hr or 1.5 to 1.9-times baseline (pre-FST) Cr levels within 48 hr (± 6 hr) prior to randomization OR KDIGO Stage II AKI and serum Cr increase 2.0 to 2.9-times baseline (pre-FST) Cr levels within 48 hr (± 6 hr) prior to randomization
- Fails to achieve a 200 mL increase in urine output within 2 hr following a 1.0 mg/kg bolus of furosemide (i.e., positive FST)
- If female of childbearing potential, must have a negative pregnancy test at Screening Is capable of providing informed consent as described in in this protocol.
Who cannot join
- Receiving hemodialysis or peritoneal dialysis
- Prior renal transplant (other organ transplants are not excluded)
- Known baseline (pre-FST) estimated glomerular filtration rate (eGFR) ≤ 20 mL/min
- Evidence of hydronephrosis or obstructive uropathy confirmed by renal ultrasound (for subjects without a documented ultrasound, the
- Investigator will determine if a renal ultrasound is indicated, consistent with the standard of care (SOC)
- Hepatic encephalopathy, Child class C cirrhosis, and/or clinical suspicion of hepatorenal syndrome
Show all 14Show fewer
- International normalized ratio (INR) ≤ 3.0, unless on stable long-term warfarin therapy within 2 weeks prior to randomization
- Known human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection
- Known coronavirus (COVID-19) infection
- White blood cell count (WBC) < 2,000/μL and/or platelet count < 30,000/μL at the time of Screening
- A sequential organ failure assessment (SOFA) score > 10 during Screening
- Subjects requiring 3 or more vasopressor agents of any combination to maintain a mean arterial pressure > 65 mm Hg
- Unwilling to participate in follow-up phone surveys up to 180 days post-treatment
- Are enrolled in another interventional research study or have participated in another interventional study within 14 days of Screening.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
University of New Mexico Health Science Center
Albuquerque, New Mexico, 87131
Emory University School of Medicine
Atlanta, Georgia, 30303
Southeast Renal Research Institute
Chattanooga, Tennessee, 37404
University of Missouri - Dept. of Surgery
Columbia, Missouri, 65212
Baylor Scott and White Research Institute - Dallas Clinical Trials Office
Dallas, Texas, 75246
New York-Presbyterian Medical Center of Queens
Flushing, New York, 11355
Emory Johns Creek Hospital
Johns Creek, Georgia, 30097
California Institute of Renal Research
La Mesa, California, 91942
University of Kentucky
Lexington, Kentucky, 40536
University of Arkansas Medical Sciences (UAMS)
Little Rock, Arkansas, 72205
Ronald Reagan UCLA Medical Center
Los Angeles, California, 900953
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157-1009
About this study
Official title: A Prospective, Double-Blind, Placebo-controlled Study of Suramin in Subjects With Furosemide-Resistant Acute Kidney Injury (AKI): Efficacy in Preventing Dialysis Dependent AKI
This is a prospective, double-blind, randomized, placebo-controlled study to assess the effects of suramin as a potential treatment option to prevent subjects with AKI from progressing to Kidney Disease Improving Global Outcomes (KDIGO) Stage III or dialysis dependent AKI.
- Conditions
- Acute Kidney Injury
- Being tested
- Suramin, Placebo
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuraminDrug
Suramin is administered via IV infusion as a single dose of 3 mg/kg
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Suramin | Experimental | Not described Receives: Drug: Suramin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate and compare the efficacy of a single 3.0 mg/kg infusion of suramin versus placebo in subjects with diuretic unresponsive AKI
The difference between the effect of a 3.0 mg/kg infusion of suramin versus placebo will be based on meeting 2 or more of the composite event endpoints of: peak serum creatinine (Cr) of 6 mg/dL or above from investigational product (IP) infusion through Day or progression to KDIGO Stage III within 72 hours (hr) from IP infusion or death or dialysis from IP infusion through Day 7.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2020
- Study start13 Nov 2020
- Primary completion17 Apr 2023
- Study completion22 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rediscovery Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04496596
- Sponsor's protocol ID
- RLS003-02-001
- Status last verified
- May 2023
- First submitted
- 29 Jul 2020
- Last updated
- 3 May 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Double-Blind, Placebo-controlled Study of Suramin in Subjects With Furosemide-Resistant Acute Kidney Injury (AKI): Efficacy in Preventing Dialysis Dependent AKI
- ClinicalTrials.gov ID
- NCT04496596
- Acronym / sponsor ID
- RLS003-02-001
- Conditions
- Acute Kidney Injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Rediscovery Life SciencesIndustry (pharma, biotech, devices)
- Study start
- 13 Nov 2020 (actual)
- Primary completion
- 17 Apr 2023 (actual)
- Study completion
- 22 Dec 2023 (estimated)
- First posted
- 3 Aug 2020 (actual)
- 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 is a prospective, double-blind, randomized, placebo-controlled study to assess the effects of suramin as a potential treatment option to prevent subjects with AKI from progressing to Kidney Disease Improving Global Outcomes (KDIGO) Stage III or dialysis dependent AKI.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suramin | Experimental | Drug: Suramin |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 18 years of age at the time of signing the informed consent
- KDIGO Stage I AKI and a serum Cr increase ≥ 0.3 mg/dL within 48 hr or 1.5 to 1.9-times baseline (pre-FST) Cr levels within 48 hr (± 6 hr) prior to randomization OR KDIGO Stage II AKI and serum Cr increase 2.0 to 2.9-times baseline (pre-FST) Cr levels within 48 hr (± 6 hr) prior to randomization
- Fails to achieve a 200 mL increase in urine output within 2 hr following a 1.0 mg/kg bolus of furosemide (i.e., positive FST)
- If female of childbearing potential, must have a negative pregnancy test at Screening Is capable of providing informed consent as described in in this protocol.
Key exclusion criteria (14 listed)
- Receiving hemodialysis or peritoneal dialysis
- Prior renal transplant (other organ transplants are not excluded)
- Known baseline (pre-FST) estimated glomerular filtration rate (eGFR) ≤ 20 mL/min
- Evidence of hydronephrosis or obstructive uropathy confirmed by renal ultrasound (for subjects without a documented ultrasound, the
- Investigator will determine if a renal ultrasound is indicated, consistent with the standard of care (SOC)
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 |
|---|---|---|
| SuraminSuramin is administered via IV infusion as a single dose of 3 mg/kg | Drug | Suramin |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
To evaluate and compare the efficacy of a single 3.0 mg/kg infusion of suramin versus placebo in subjects with diuretic unresponsive AKI
Time frame: 7 days
The difference between the effect of a 3.0 mg/kg infusion of suramin versus placebo will be based on meeting 2 or more of the composite event endpoints of: peak serum creatinine (Cr) of 6 mg/dL or above from investigational product (IP) infusion through Day or progression to KDIGO Stage III within 72 hours (hr) from IP infusion or death or dialysis from IP infusion through Day 7.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Suramin in people with Acute Kidney Injury, run by Rediscovery Life Sciences at 12 sites 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 14 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 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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?
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?
To evaluate and compare the efficacy of a single 3.0 mg/kg infusion of suramin versus placebo in subjects with diuretic unresponsive AKI (time frame: 7 days). 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 3 May 2023.