Acute (Cellular) Renal Allograft RejectionPhase 4NCT02102854
Single Dose rATG for Renal Allograft Rejection
A Phase 4 study testing rATG in people with Acute (Cellular) Renal Allograft Rejection, run by The Methodist Hospital Research Institute at 1 site in United States.
Trial summary
Rabbit antithymocyte globulin (rATG) is approved for the treatment of acute rejection following kidney transplantation and is routinely administered as a series of 5-7 consecutive daily doses via central intravenous catheter.Single large-doses of rATG have been shown to have equivalent safety and efficacy profile… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acute (Cellular) Renal Allograft Rejection
- What is being tested?
- rATG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Oct 2021
- Phase
- Phase 4
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female subjects aged 18 years or older
- Experiencing a biopsy-proven acute rejection episode which:
- will require the use of rATG based on severity, or
- is exhibiting resistance to corticosteroid treatment, defined as failure of the serum creatinine to decrease after at least 3 days of corticosteroid treatment (≥200 mg/day of methylprednisolone or equivalent)
Who cannot join
- Patients with known severe allergy to antithymocyte globulin or rabbits
- Rejection episode requiring the use of therapeutic plasma exchange immediately subsequent to rATG administration
- Currently receiving any investigational drug or treatments
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Houston Methodist Hospital
Houston, Texas, 77030
Darrel W Cleere, RN, CCRC, 713-441-6232, dwcleere@houstonmethodist.org
Samir J Patel, Pharm.D.
About this study
Official title: Single Dose rATG for Treatment of Acute Renal Allograft Rejection
Rabbit antithymocyte globulin (rATG) is approved for the treatment of acute rejection following kidney transplantation and is routinely administered as a series of 5-7 consecutive daily doses via central intravenous catheter.Single large-doses of rATG have been shown to have equivalent safety and efficacy profile compared to the standard daily protocol when used as an induction agent but there are no reported experiences of its use for rejection treatment. Plan to study a single-dose rATG infusion compared to standard rATG administration including correlation to length of hospital stay and hospital costs.
Read the detailed description
Rabbit antithymocyte globulin (rATG) is approved for the treatment of acute rejection following kidney transplantation and is routinely administered as a series of 5-7 consecutive daily doses via central intravenous catheter. This prolonged course is not consistent with the Medicare diagnosis-related group (DRG) for acute rejection which limits rejection admission to 3 days. The prolonged hospitalization results in increased medical costs and uniform financial loss to the hospital for patients admitted under this DRG. In addition there is a patient related toll of the prolonged hospitalization and a potential for additional hospital acquired complications. Single large-doses of rATG have been shown to have equivalent safety and efficacy profile compared to the standard daily protocol when used as an induction agent but there are no reported experiences of its use for rejection treatment. The investigators hypothesize that single-dose rATG infusion will be as safe and efficacious as standard rATG administration when used for rejection treatment and would result in significant reduction in the length of hospital stay (LOS) and hospital costs for rejection treatment.
- Being tested
- rATG
- Keywords
- kidney transplantation, acute rejection, rabbit antithymocyte globulin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rATGDrug
Also called Rabbit antithymocyte globulin, Thymoglobulin, ATG
Infusion of horse or rabbit-derived antibodies against human T cells, used to prevent \& treat acute rejection in organ transplantation
| Study group | Role | What they receive |
|---|---|---|
| Standard dose rATG | Active comparator | Standard dose rATG given as daily infusions of 1.5 mg/kg x 4-5 days Receives: Drug: rATG |
| Single dose rATG | Experimental | Single dose rATG give as 2 consecutive 3 mg/kg IV infusions to be completed over a 24-36 hour duration Receives: Drug: rATG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital length of hospitalization (days)
The length of hospitalization for treatment of renal allograft rejection in days will be determined which should be an average of 5-7 days
Measured: 7 days
Secondary outcomes (1)
Infusion related symptoms
Incidence of grade 1, 2, or 3 infusion-related symptoms, graded according to common terminology criteria will be determined during the patient's hospital admission, which should be an average of 5-7 days
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 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionMar 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute (Cellular) Renal Allograft RejectionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samir J. Patel, The Methodist Hospital Research Institute
- Investigators
- Samir Patel, PharmD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02102854
- Sponsor's protocol ID
- Pro00003442
- Other IDs
- 0809-0111
- Status last verified
- Sep 2020
- First submitted
- 26 Mar 2014
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- 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 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose rATG for Treatment of Acute Renal Allograft Rejection
- ClinicalTrials.gov ID
- NCT02102854
- Acronym / sponsor ID
- Pro00003442
- Keywords
- kidney transplantation, acute rejection, rabbit antithymocyte globulin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 3 Apr 2014 (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.
Rabbit antithymocyte globulin (rATG) is approved for the treatment of acute rejection following kidney transplantation and is routinely administered as a series of 5-7 consecutive daily doses via central intravenous catheter.Single large-doses of rATG have been shown to have equivalent safety and efficacy profile compared to the standard daily protocol when used as an induction agent but there are no reported experiences of its use for rejection treatment. Plan to study a single-dose rATG infusion compared to standard rATG administration including correlation to length of hospital stay and hospital costs.
Detailed description
Rabbit antithymocyte globulin (rATG) is approved for the treatment of acute rejection following kidney transplantation and is routinely administered as a series of 5-7 consecutive daily doses via central intravenous catheter. This prolonged course is not consistent with the Medicare diagnosis-related group (DRG) for acute rejection which limits rejection admission to 3 days. The prolonged hospitalization results in increased medical costs and uniform financial loss to the hospital for patients admitted under this DRG. In addition there is a patient related toll of the prolonged hospitalization and a potential for additional hospital acquired complications. Single large-doses of rATG have been shown to have equivalent safety and efficacy profile compared to the standard daily protocol when used as an induction agent but there are no reported experiences of its use for rejection treatment. The investigators hypothesize that single-dose rATG infusion will be as safe and efficacious as standard rATG administration when used for rejection treatment and would result in significant reduction in the length of hospital stay (LOS) and hospital costs for rejection treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard dose rATG | Active comparator | Drug: rATGStandard dose rATG given as daily infusions of 1.5 mg/kg x 4-5 days |
| Single dose rATG | Experimental | Drug: rATGSingle dose rATG give as 2 consecutive 3 mg/kg IV infusions to be completed over a 24-36 hour duration |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or female subjects aged 18 years or older
- Experiencing a biopsy-proven acute rejection episode which:
Key exclusion criteria (3 listed)
- Patients with known severe allergy to antithymocyte globulin or rabbits
- Rejection episode requiring the use of therapeutic plasma exchange immediately subsequent to rATG administration
- Currently receiving any investigational drug or treatments
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 |
|---|---|---|
| rATGAlso: Rabbit antithymocyte globulin, Thymoglobulin, ATGInfusion of horse or rabbit-derived antibodies against human T cells, used to prevent \& treat acute rejection in organ transplantation | Drug | Single dose rATG, Standard dose rATG |
Primary outcome
Hospital length of hospitalization (days)
Time frame: 7 days
The length of hospitalization for treatment of renal allograft rejection in days will be determined which should be an average of 5-7 days
1 secondary outcome
Infusion related symptoms
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
- Individual participant dataSharing planned: No
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Blood Biomarkers in Pediatric Kidney Transplant Recipients
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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.
Samir Patel, PharmD principal investigator
The Methodist Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing rATG in people with Acute (Cellular) Renal Allograft Rejection, run by The Methodist Hospital Research Institute 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 3 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 Sep 2020. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Samir J Patel, Pharm.D. (713-441-2168, spatel2@houstonmethodist.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital length of hospitalization (days) (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 Sep 2020.