Transplant;Failure,KidneyNCT03310905
Abdominal Wall Transplant
A study testing Abdominal Wall Transplant with another solid organ transplant and Abdominal Wall Transplant alone in people with Transplant;Failure,Kidney and Transplant; Failure, Liver, run by Duke University at 1 site in United States.
Trial summary
The purpose of this protocol is to determine the safety and efficacy of abdominal wall transplantation as a treatment for the reconstruction of abdominal wall defects. Abdominal wall transplantation may be performed alone or in combination with another transplant. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Transplant;Failure,Kidney, Transplant; Failure, Liver, Transplant; Failure, Bowel
- What is being tested?
- Abdominal Wall Transplant with another solid organ transplant and Abdominal Wall Transplant alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Candidates between 18-65 years old
- Willingness and legal ability to give consent
- Abdominal Wall in combination with another organ transplant: they must be eligible for the non-vascularized composite allograft organ transplant at Duke
Who cannot join
- Malignancy at evaluation or history of malignancy that precludes transplantation
- Pregnancy: Women who are of childbearing potential must have a negative serum pregnancy test within 48 hours of transplant and agree to use reliable contraception with two contraceptive methods for a minimum of 2 years following abdominal wall transplantation. Subjects seeking to become pregnant following 2 years will be made aware during the consent process that the effect of pregnancy on the transplanted abdominal wall and vice versa is unknown.
- Medical exclusion criteria for general anesthesia
- Ongoing substance abuse or history of untreated substance abuse
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Abdominal Wall Transplantation for the Reconstruction of Abdominal Wall Defects as Adjunct to Abdominal Solid Organ Transplantation
The purpose of this protocol is to determine the safety and efficacy of abdominal wall transplantation as a treatment for the reconstruction of abdominal wall defects. Abdominal wall transplantation may be performed alone or in combination with another transplant.
Read the detailed description
Within this protocol we propose to perform abdominal wall transplantation in 5 subjects, either as an isolated abdominal wall or in combination with another organ transplant. Each subject will be followed for a study period of 18 months.
Participants receiving an isolated abdominal wall or abdominal wall in combination with another organ transplant will receive the standard immunosuppression therapy as the non-vascularized composite allograft organ transplant. These patients will be studied to determine efficacy of the abdominal wall transplant to restore function of the defective abdominal wall for a study period of 18 months at Duke University Medical Center.
- Conditions
- Transplant;Failure,Kidney, Transplant; Failure, Liver, Transplant; Failure, Bowel, Abdominal Wall Defect, Abdominal Wall Fistula, Abdominal Wall Hernia
- Being tested
- Abdominal Wall Transplant with another solid organ transplant, Abdominal Wall Transplant alone
- Keywords
- Research, Transplant, Abdominal Wall, Hernia
- Medical subject headings
- Hernia, Abdominal, Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal Wall Transplant with another solid organ transplantProcedure or surgery
Transplant of abdominal wall in combination with another solid organ transplant.
Abdominal Wall Transplant aloneProcedure or surgery
Abdominal Wall Transplant alone
| Study group | Role | What they receive |
|---|---|---|
| Isolated Abdominal Wall Transplant | Experimental | Not described Receives: Procedure: Abdominal Wall Transplant alone |
| Abdominal Wall with Solid Organ Transplant | Experimental | Not described Receives: Procedure: Abdominal Wall Transplant with another solid organ transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with a viable abdominal wall transplant at 18 months
Measured: up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study start1 May 2018
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplant;Failure,KidneyStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Linda Cendales, MD, Kadiyala Ravindra, M.D., Detlev Erdmann, M.D.
- Responsible party
- Sponsor
- Investigators
- Linda Cendales, MD, Principal investigator, Duke UniversityKadiyala Ravindra, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03310905
- Sponsor's protocol ID
- Pro00084054
- Status last verified
- Jan 2026
- First submitted
- 11 Oct 2017
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At this time all data will be de-identified and there is no plan to make individual participant data available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal Wall Transplantation for the Reconstruction of Abdominal Wall Defects as Adjunct to Abdominal Solid Organ Transplantation
- ClinicalTrials.gov ID
- NCT03310905
- Acronym / sponsor ID
- Pro00084054
- Conditions
- Transplant;Failure,Kidney, Transplant; Failure, Liver, Transplant; Failure, Bowel, Abdominal Wall Defect, Abdominal Wall Fistula, Abdominal Wall Hernia
- Keywords
- Research, Transplant, Abdominal Wall, Hernia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Linda Cendales, MD, Kadiyala Ravindra, M.D., Detlev Erdmann, M.D.
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 16 Oct 2017 (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.
The purpose of this protocol is to determine the safety and efficacy of abdominal wall transplantation as a treatment for the reconstruction of abdominal wall defects. Abdominal wall transplantation may be performed alone or in combination with another transplant.
Detailed description
Within this protocol we propose to perform abdominal wall transplantation in 5 subjects, either as an isolated abdominal wall or in combination with another organ transplant. Each subject will be followed for a study period of 18 months.
Participants receiving an isolated abdominal wall or abdominal wall in combination with another organ transplant will receive the standard immunosuppression therapy as the non-vascularized composite allograft organ transplant. These patients will be studied to determine efficacy of the abdominal wall transplant to restore function of the defective abdominal wall for a study period of 18 months at Duke University Medical Center.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isolated Abdominal Wall Transplant | Experimental | Procedure: Abdominal Wall Transplant alone |
| Abdominal Wall with Solid Organ Transplant | Experimental | Procedure: Abdominal Wall Transplant with another solid organ transplant |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Candidates between 18-65 years old
- Willingness and legal ability to give consent
- Abdominal Wall in combination with another organ transplant: they must be eligible for the non-vascularized composite allograft organ transplant at Duke
Key exclusion criteria (4 listed)
- Malignancy at evaluation or history of malignancy that precludes transplantation
- Pregnancy: Women who are of childbearing potential must have a negative serum pregnancy test within 48 hours of transplant and agree to use reliable contraception with two contraceptive methods for a minimum of 2 years following abdominal wall transplantation. Subjects seeking to become pregnant following 2 years will be made aware during the consent process that the effect of pregnancy on the transplanted abdominal wall and vice versa is unknown.
- Medical exclusion criteria for general anesthesia
- Ongoing substance abuse or history of untreated substance abuse
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 |
|---|---|---|
| Abdominal Wall Transplant with another solid organ transplantTransplant of abdominal wall in combination with another solid organ transplant. | Procedure or surgery | Abdominal Wall with Solid Organ Transplant |
| Abdominal Wall Transplant aloneAbdominal Wall Transplant alone | Procedure or surgery | Isolated Abdominal Wall Transplant |
Primary outcome
Number of subjects with a viable abdominal wall transplant at 18 months
Time frame: up to 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: No. At this time all data will be de-identified and there is no plan to make individual participant data available to other researchers.
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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.
Linda Cendales, MD principal investigator
Duke University
Kadiyala Ravindra, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal Wall Transplant with another solid organ transplant and Abdominal Wall Transplant alone in people with Transplant;Failure,Kidney and Transplant; Failure, Liver, run by Duke University 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 7 Jan 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Linda Cendales, MD (919-681-7514, linda.cendales@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with a viable abdominal wall transplant at 18 months (time frame: up to 18 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 7 Jan 2026.