End Stage Renal DiseasePhase 1/2NCT01958970
Effects of PINTA 745 in End Stage Renal Disease (ESRD) Patients Who Require Hemodialysis and Have Protein Energy Wasting
A Phase 1/2 study testing PINTA 745 in people with End Stage Renal Disease and Kidney Disease, run by Pinta Biotherapeutics at 6 sites in United States.
Trial summary
This is a pilot study to assess the safety, pharmacokinetics and effectiveness of PINTA 745 or placebo in treating protein energy wasting (PEW) in patients receiving maintenance hemodialysis (MHD). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- End Stage Renal Disease, Kidney Disease, Protein Energy Wasting
- What is being tested?
- PINTA 745
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 6 sitesUnited States
- Study dates
- Jan 2014to Jan 2016
- Phase
- Phase 1/2
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ESRD patient and on outpatient maintenance hemodialysis for ≥ 6 months
- Adequate dialysis with Kt/V ≥ 1.2 on two occasions within 12 weeks of enrollment
- Undergoing dialysis at least 3 times per week, on average
- Serum albumin ≤ 3.8g/dL within 60 days of enrollment
- Able and willing to provide Informed consent
Who cannot join
- Presence of an indwelling central vascular catheter
- Current medical condition that would interfere with ability to perform physical function tests
- Active infection requiring hospitalization or antibiotics within the past month
- Major surgery within past 3 months, minor surgery within the past 4 months
- Dialysis access revision/angioplasty/replacement within the past 2 weeks
- History of renal transplant, whether or not functional, within 2 years (however, if graft has been removed, patient will be considered eligible) or plans to undergo renal transplantation within 6 months
Show all 13Show fewer
- History of neoplasia, except non-melanoma skin cancers, with a 30% probability of recurrence within 12 months
- Current treatment with appetite stimulants, anabolic steroids or growth hormone
- Clinically significant heart disease
- Difficulty swallowing food or liquid
- If female, currently breast feeding
- If female, pregnant
- If female or male, unwilling to use a highly effective method of contraception
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
DaVita Clinical Research
Lakewood, Colorado, 80228
DaVita Clinical Research
Minneapolis, Minnesota, 55404
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Orlando Clinical Research Center
Orlando, Florida, 32809
Clinical Advancement Center, PLLC
San Antonio, Texas, 78215
University of Washington
Seattle, Washington, 98104
About this study
Official title: A Randomized, Double-blind, Pilot Study of PINTA 745, an Anti-myostatin Peptibody, in Patients With End Stage Renal Disease Who Require Maintenance Hemodialysis and Have Protein Energy Wasting
This is a pilot study to assess the safety, pharmacokinetics and effectiveness of PINTA 745 or placebo in treating protein energy wasting (PEW) in patients receiving maintenance hemodialysis (MHD).
Read the detailed description
This is a randomized (participants will be assigned by chance to study treatments), double-blind (participants and study personnel will not know the identity of the study treatments), placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial)-controlled study in patients who receive maintenance hemodialysis. Three participants will receive PINTA 745 for every participant that receives placebo. PINTA 745 or placebo will be taken intravenously once per week following dialysis.
The study period will consist of screening, treatment for 12 weeks, and follow up for 8 weeks. Evaluations will be performed to assess the safety, pharmacokinetics (study of what the body does to a drug), pharmacodynamics (study of what a drug does to the body) and effectiveness in treating protein energy wasting (such as increasing muscle size and muscle function) throughout the study.
- Being tested
- PINTA 745, Placebo
- Keywords
- End Stage Renal Disease, ESRD, Maintenance Hemodialysis, Hemodialysis, Dialysis, MHD, Protein Energy Wasting, PEW
- Medical subject headings
- Kidney Failure, Chronic, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PINTA 745Drug
PINTA 745 will be administered once weekly by IV infusion.
Cohort dose schedules:
- 3mg/kg weekly for 12 weeks
- 3mg/kg for 3 weeks, followed by 1mg/kg for 9 weeks
- 6mg/kg for 3 weeks, followed by 2mg/kg for 9 weeks
PlaceboDrug
Placebo will be administered once weekly by IV infusion.
Cohort dose schedules:
- 3mg/kg weekly for 12 weeks
- 3mg/kg for 3 weeks, followed by 1mg/kg for 9 weeks
- 6mg/kg for 3 weeks, followed by 2mg/kg for 9 weeks
| Study group | Role | What they receive |
|---|---|---|
| PINTA 745 | Experimental | Not described Receives: Drug: PINTA 745 |
| 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.
Maximum Tolerated Dose and Percent Changes in Lean Body Mass (LBM)
To evaluate the safety, dose-limiting toxicities (DLTs), maximum tolerated dose (MTD) and pharmacokinetics of PINTA 745 and to evaluate percentage change in LBM relative to baseline at 12 weeks, via dual-energy x-ray absorptiometry(DXA) scans, in the group receiving PINTA 745 at the MTD (or if no MTD is reached, at the recommended phase 2 dose)
Measured: MTD will be assessed after the last patient in Cohort 1A and Cohort 2A complete 28 days on treatment. LBM will be assessed for comparing baseline to Week 12
Secondary outcomes (2)
Change in Muscle Composition - Lean Body Mass (LBM), Appendicular Lean Mass (ALM) and Mid Upper Arm Muscle Circumference (MUAMC)
To evaluate the change in LBM and ALM via CT and dual-energy x-ray absorptiometry (DXA) scans relative to baseline at 12, 16 and 20 weeks. To evaluate change relative to baseline in MUAMC at 5, 9, 16 and 20 weeks.
Measured: Baseline through Week 20
Change in Physical Function
To evaluate change in physical function as measured by the Stair Climbing Power Test (SCPT) and the 6 Minute Walk Test (6MWT) relative to baseline at 5, 9, 12, 16 and 20 weeks
Measured: Baseline through Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2013 (estimated)
- Study startJan 2014
- Primary completionNov 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pinta Biotherapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher Haqq, MD, PhD, Study director, Pinta Biotherapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01958970
- Sponsor's protocol ID
- 745-201
- Status last verified
- Apr 2018
- First submitted
- 7 Oct 2013
- Last updated
- 11 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Pilot Study of PINTA 745, an Anti-myostatin Peptibody, in Patients With End Stage Renal Disease Who Require Maintenance Hemodialysis and Have Protein Energy Wasting
- ClinicalTrials.gov ID
- NCT01958970
- Acronym / sponsor ID
- 745-201
- Keywords
- End Stage Renal Disease, ESRD, Maintenance Hemodialysis, Hemodialysis, Dialysis, MHD, Protein Energy Wasting, PEW
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Pinta BiotherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 9 Oct 2013 (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 is a pilot study to assess the safety, pharmacokinetics and effectiveness of PINTA 745 or placebo in treating protein energy wasting (PEW) in patients receiving maintenance hemodialysis (MHD).
Detailed description
This is a randomized (participants will be assigned by chance to study treatments), double-blind (participants and study personnel will not know the identity of the study treatments), placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial)-controlled study in patients who receive maintenance hemodialysis. Three participants will receive PINTA 745 for every participant that receives placebo. PINTA 745 or placebo will be taken intravenously once per week following dialysis.
The study period will consist of screening, treatment for 12 weeks, and follow up for 8 weeks. Evaluations will be performed to assess the safety, pharmacokinetics (study of what the body does to a drug), pharmacodynamics (study of what a drug does to the body) and effectiveness in treating protein energy wasting (such as increasing muscle size and muscle function) throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PINTA 745 | Experimental | Drug: PINTA 745 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ESRD patient and on outpatient maintenance hemodialysis for ≥ 6 months
- Adequate dialysis with Kt/V ≥ 1.2 on two occasions within 12 weeks of enrollment
- Undergoing dialysis at least 3 times per week, on average
- Serum albumin ≤ 3.8g/dL within 60 days of enrollment
- Able and willing to provide Informed consent
Key exclusion criteria (13 listed)
- Presence of an indwelling central vascular catheter
- Current medical condition that would interfere with ability to perform physical function tests
- Active infection requiring hospitalization or antibiotics within the past month
- Major surgery within past 3 months, minor surgery within the past 4 months
- Dialysis access revision/angioplasty/replacement within the past 2 weeks
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 |
|---|---|---|
| PINTA 745PINTA 745 will be administered once weekly by IV infusion. Cohort dose schedules: * 3mg/kg weekly for 12 weeks * 3mg/kg for 3 weeks, followed by 1mg/kg for 9 weeks * 6mg/kg for 3 weeks, followed by 2mg/kg for 9 weeks | Drug | PINTA 745 |
| PlaceboPlacebo will be administered once weekly by IV infusion. Cohort dose schedules: * 3mg/kg weekly for 12 weeks * 3mg/kg for 3 weeks, followed by 1mg/kg for 9 weeks * 6mg/kg for 3 weeks, followed by 2mg/kg for 9 weeks | Drug | Placebo |
Primary outcome
Maximum Tolerated Dose and Percent Changes in Lean Body Mass (LBM)
Time frame: MTD will be assessed after the last patient in Cohort 1A and Cohort 2A complete 28 days on treatment. LBM will be assessed for comparing baseline to Week 12
To evaluate the safety, dose-limiting toxicities (DLTs), maximum tolerated dose (MTD) and pharmacokinetics of PINTA 745 and to evaluate percentage change in LBM relative to baseline at 12 weeks, via dual-energy x-ray absorptiometry(DXA) scans, in the group receiving PINTA 745 at the MTD (or if no MTD is reached, at the recommended phase 2 dose)
2 secondary outcomes
Change in Muscle Composition - Lean Body Mass (LBM), Appendicular Lean Mass (ALM) and Mid Upper Arm Muscle Circumference (MUAMC)
Time frame: Baseline through Week 20
Change in Physical Function
Time frame: Baseline through Week 20
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2018.
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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.
Christopher Haqq, MD, PhD study director
Pinta Biotherapeutics
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PINTA 745 in people with End Stage Renal Disease and Kidney Disease, run by Pinta Biotherapeutics at 6 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 5 inclusion and 13 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: finished, as of the sponsor's last update on 11 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum Tolerated Dose and Percent Changes in Lean Body Mass (LBM) (time frame: MTD will be assessed after the last patient in Cohort 1A and Cohort 2A complete 28 days on treatment. LBM will be assessed for comparing baseline to Week 12). 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 11 Apr 2018.