CKD (Chronic Kidney Disease) Stage 5TPhase 4PAISPKNCT03470961
Observational Study to Evaluate the Safety and Efficacy of Polyclonal Antibodies in Simultaneous Pancreas Kidney Transplant Recipients
A Phase 4 study testing Anti-Tlymphocyte Globulins and Anti-Thymocyte Globulins in people with CKD (Chronic Kidney Disease) Stage 5T and Diabetes Mellitus, run by Tianjin First Central Hospital at 1 site in China.
Trial summary
A single-centre, prospective, observational study to evaluate the safety and efficacy of Polyclonal Antibodies in simultaneous Pancreas Kidney Transplant recipients. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- CKD (Chronic Kidney Disease) Stage 5T, Diabetes Mellitus, Simultaneous Pancreas Kidney Transplantation
- What is being tested?
- Anti-Tlymphocyte Globulins and Anti-Thymocyte Globulins
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2018to 1 Mar 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
- with end-stage,diabetic nephropathy(type1or 2)
- Patients scheduled to undergo SPK with compatible ABO blood type.
- Peak PRA <50%
- Females of childbearing potential must have a negative pregnancy test within 48hrs prior to randomization and reliable methods of contraception should be started 4 weeks prior to and during the whole study.
- Patient must have signed the Patient Informed Consent Form.
- Patient must receive a primary simultaneous pancreas/kidney (SPK) cadaveric transplant, with either intestinal or bladder and either portal or systemic venous drainages.
Who cannot join
- Patient is pregnant or breastfeeding.
- Patient has a positive T-cell crossmatch on the most recent serum specimen.
- Patient is known for active liver disease or has significant liver disease, defined by ASAT and ALAT serum levels greater than 3 times the upper limit of normal.
- Patient has malignancy or history of malignancy, with the exception of adequately treated localised squamous cell or basal cell carcinoma, without recurrence.
- Patient has been included in another clinical trial protocol for any investigational drug within 4 weeks prior to randomisation.
- Patient has any form of substance abuse, psychiatric disorder or condition, which, in the opinion of the investigator, may invalidate communication.
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- Patient receives a SPK transplant from a living donor, or receives segmental pancreatic transplant, or a previous kidney transplant alone.
- Donor is older than 55 years of age
- patients with bacterial, viral or mycotic infections which are not under therapeutically control
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Polyclonal Antibodies in Simultaneous Pancreas Kidney Transplant Recipients: Single-centre, Prospective, Observational Study
A single-centre, prospective, observational study to evaluate the safety and efficacy of Polyclonal Antibodies in simultaneous Pancreas Kidney Transplant recipients.
Read the detailed description
Polyclonal antibody mainly contains Antit-Tlymphocyte globulins(Grafalon) and Anti-thymocyte globulins(ATG). To investigate the efficacy and safety of polyclonal antibodies induction regimen using Grafalon compared with ATG in de novo simultaneous pancreas kidney transplant recipients. The primary analysis of this study is to demonstrate the non-inferiority of the two regimens with regard to efficacy, defined as failure rate.
The secondary objective of the study is the assessment of safety and further efficacy parameters in terms of incidence of acute rejections, graft/patient survival, DGF(delayed graft function), pancreas function and renal function
- Conditions
- CKD (Chronic Kidney Disease) Stage 5T, Diabetes Mellitus, Simultaneous Pancreas Kidney Transplantation
- Being tested
- Anti-Tlymphocyte Globulins, Anti-Thymocyte Globulins
- Keywords
- Grafalon ATG SPK
- Medical subject headings
- Renal Insufficiency, Chronic, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-Tlymphocyte GlobulinsDrug
Also called Grafalon, ATG-F
Induction therapy regimen in simultaneous pancreas kidney transplantation
Anti-Thymocyte GlobulinsDrug
Also called ATG
Induction therapy regimen in simultaneous pancreas kidney transplantation
| Study group | Role | What they receive |
|---|---|---|
| Anti-Tlymphocyte Globulins | Experimental | intravenous，2mg/kg/d，for 5 days Receives: Drug: Anti-Tlymphocyte Globulins |
| Anti-thymocyte Globulins | Active comparator | intravenous，1.5mg/kg/d，for 4 days Receives: Drug: Anti-Thymocyte Globulins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse event
Incidence of patient's death,graft loss,acute rejection
Measured: up to 3 months post-transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study start1 Mar 2018
- Primary completion1 Mar 2021 (estimated)
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CKD (Chronic Kidney Disease) Stage 5TStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin First Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yingxin FU.MD, Tianjin First Central Hospital
- Investigators
- Yingxin FU, M.D, Principal investigator, Tianjin First Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03470961
- Sponsor's protocol ID
- 2018N017KY
- Acronym
- PAISPK
- Status last verified
- Mar 2018
- First submitted
- 13 Mar 2018
- Last updated
- 20 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Burkhalter F, Schaub S, Bucher C, Gurke L, Bachmann A, Hopfer H, Dickenmann M, Steiger J, Binet I. A Comparison of Two Types of Rabbit Antithymocyte Globulin Induction Therapy in Immunological High-Risk Kidney Recipients: A Prospective Randomized Control Study. PLoS One. 2016 Nov 17;11(11):e0165233. doi: 10.1371/journal.pone.0165233. eCollection 2016.
PubMed 27855166Kuypers DR, Malaise J, Claes K, Evenepoel P, Maes B, Coosemans W, Pirenne J, Vanrenterghem Y; Euro-SPK Study Group. Secondary effects of immunosuppressive drugs after simultaneous pancreas-kidney transplantation. Nephrol Dial Transplant. 2005 May;20 Suppl 2:ii33-9, ii62. doi: 10.1093/ndt/gfh1080.
PubMed 15814548
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Polyclonal Antibodies in Simultaneous Pancreas Kidney Transplant Recipients: Single-centre, Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT03470961
- Acronym / sponsor ID
- PAISPK / 2018N017KY
- Conditions
- CKD (Chronic Kidney Disease) Stage 5T, Diabetes Mellitus, Simultaneous Pancreas Kidney Transplantation
- Keywords
- Grafalon ATG SPK
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Tianjin First Central HospitalUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 20 Mar 2018 (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.
A single-centre, prospective, observational study to evaluate the safety and efficacy of Polyclonal Antibodies in simultaneous Pancreas Kidney Transplant recipients.
Detailed description
Polyclonal antibody mainly contains Antit-Tlymphocyte globulins(Grafalon) and Anti-thymocyte globulins(ATG). To investigate the efficacy and safety of polyclonal antibodies induction regimen using Grafalon compared with ATG in de novo simultaneous pancreas kidney transplant recipients. The primary analysis of this study is to demonstrate the non-inferiority of the two regimens with regard to efficacy, defined as failure rate.
The secondary objective of the study is the assessment of safety and further efficacy parameters in terms of incidence of acute rejections, graft/patient survival, DGF(delayed graft function), pancreas function and renal function
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anti-Tlymphocyte Globulins | Experimental | Drug: Anti-Tlymphocyte Globulinsintravenous，2mg/kg/d，for 5 days |
| Anti-thymocyte Globulins | Active comparator | Drug: Anti-Thymocyte Globulinsintravenous，1.5mg/kg/d，for 4 days |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- with end-stage,diabetic nephropathy(type1or 2)
- Patients scheduled to undergo SPK with compatible ABO blood type.
- Peak PRA <50%
- Females of childbearing potential must have a negative pregnancy test within 48hrs prior to randomization and reliable methods of contraception should be started 4 weeks prior to and during the whole study.
- Patient must have signed the Patient Informed Consent Form.
Key exclusion criteria (9 listed)
- Patient is pregnant or breastfeeding.
- Patient has a positive T-cell crossmatch on the most recent serum specimen.
- Patient is known for active liver disease or has significant liver disease, defined by ASAT and ALAT serum levels greater than 3 times the upper limit of normal.
- Patient has malignancy or history of malignancy, with the exception of adequately treated localised squamous cell or basal cell carcinoma, without recurrence.
- Patient has been included in another clinical trial protocol for any investigational drug within 4 weeks prior to randomisation.
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 |
|---|---|---|
| Anti-Tlymphocyte GlobulinsAlso: Grafalon, ATG-FInduction therapy regimen in simultaneous pancreas kidney transplantation | Drug | Anti-Tlymphocyte Globulins |
| Anti-Thymocyte GlobulinsAlso: ATGInduction therapy regimen in simultaneous pancreas kidney transplantation | Drug | Anti-thymocyte Globulins |
Primary outcome
Incidence and severity of adverse event
Time frame: up to 3 months post-transplantation
Incidence of patient's death,graft loss,acute rejection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2018.
- Results publication: PubMed 27855166Burkhalter F, Schaub S, Bucher C, Gurke L, Bachmann A, Hopfer H, Dickenmann M, Steiger J, Binet I. A Comparison of Two Types of Rabbit Antithymocyte Globulin Induction Therapy in Immunological High-Risk Kidney Recipients: A Prospective Randomized Control Study. PLoS One. 2016 Nov 17;11(11):e0165233. doi: 10.1371/journal.pone.0165233. eCollection 2016.
- Results publication: PubMed 15814548Kuypers DR, Malaise J, Claes K, Evenepoel P, Maes B, Coosemans W, Pirenne J, Vanrenterghem Y; Euro-SPK Study Group. Secondary effects of immunosuppressive drugs after simultaneous pancreas-kidney transplantation. Nephrol Dial Transplant. 2005 May;20 Suppl 2:ii33-9, ii62. doi: 10.1093/ndt/gfh1080.
- Individual participant dataSharing planned: No
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.
Yingxin FU, M.D principal investigator
Tianjin First Central Hospital
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 Anti-Tlymphocyte Globulins and Anti-Thymocyte Globulins in people with CKD (Chronic Kidney Disease) Stage 5T and Diabetes Mellitus, run by Tianjin First Central Hospital at 1 site in China.
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 6 inclusion and 9 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 20 Mar 2018. 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 China. 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?
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?
Incidence and severity of adverse event (time frame: up to 3 months post-transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03470961, which also lists 2 linked publications.
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 20 Mar 2018.