Kidney Transplant RejectionPhase 4NCT03789006
Antithymocyte Globulin and Azathioprine Versus Basiliximab and Mycophenolate Mofetil in Living Donor Kidney Transplantation
A Phase 4 study testing Antithymocyte Immunoglobulin (Rabbit) and Interleukin 2 Receptor Antagonist in people with Kidney Transplant Rejection, run by University of Khartoum at 1 site in Sudan.
Trial summary
Kidney transplantation is the best available treatment option for patients with end stage renal disease. However, kidney transplantation requires life-long use of immunosuppressive medication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Rejection
- What is being tested?
- Antithymocyte Immunoglobulin (Rabbit) and Interleukin 2 Receptor Antagonist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSudan
- Study dates
- 21 Mar 2018to 21 Mar 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult end-stage renal disease patients
- First living donor kidney transplant.
- Moderate immunological risk.
Who cannot join
- Low immunological risk (HLA mismatches 000/100/010/110 with negative PRA).
- High immunological risk (child to mother or husband to wife transplant, 2 DR mismatches).
- Known hypersensitivity to any of the study medication.
Trial locations and contacts
1 site in 1 country.
Sudan1 site, 1 recruiting
- Recruiting
Doctor Salma Center for Kidney Diseases
Khartoum, 11111
Sarra Elamin, MD, (+249)912474666, sarraelamin@hotmail.com
Nazar Zulfo, MD, (+249)900948820, nazarzuflo@gmail.com
About this study
Official title: Efficiency of Antithymocyte Globulin and Azathioprine Versus Basiliximab and Mycophenolate Mofetil When Used in Combination With Tacrolimus and Prednisolone in Living Donor Kidney Transplantation
Kidney transplantation is the best available treatment option for patients with end stage renal disease. However, kidney transplantation requires life-long use of immunosuppressive medication. Because of the high cost of these medications we need to carefully evaluate the cost-effectiveness of each drug regimen, especially in low-middle income countries. The objective of this clinical trial is to compare the efficiency and cost of two immunosuppressive protocols after living donor kidney transplantation: (1) antithymocyte globulin, tacrolimus, azathioprine and prednisolone versus (2) basiliximab, tacrolimus, mycophenolate mofetil and prednisolone.
- Conditions
- Kidney Transplant Rejection
- Being tested
- Antithymocyte Immunoglobulin (Rabbit), Interleukin 2 Receptor Antagonist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antithymocyte Immunoglobulin (Rabbit)Drug
Also called grafalon
Induction agent for living donor kidney transplantation
Interleukin 2 Receptor AntagonistDrug
Also called Basiliximab
Induction agent for living donor kidney transplantation
| Study group | Role | What they receive |
|---|---|---|
| ATG | Active comparator | Induction with antithymocyte immunoglobulin (Rabbit) (Grafalon) and maintenance with tacrolimus, azathioprine and prednisolone Receives: Drug: Antithymocyte Immunoglobulin (Rabbit) |
| BAS | Active comparator | Induction with interleukin 2 receptor antagonist (basiliximab) and maintenance with tacrolimus, mycophenolate mofetil and prednisolone Receives: Drug: Interleukin 2 Receptor Antagonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute rejection
The incidence of acute rejection will include clinically diagnosed and biopsy proven acute rejection. Clinically diagnosed rejection includes at least 30% acute rise in serum creatinine level. Biopsy proven rejection will include both cellular and antibody mediated rejection according to Banff 2017 criteria
Measured: 6 months post kidney transplant
One year graft survival
One year kidney allograft survival, uncensored for patient death
Measured: 1 year post kidney transplant
Secondary outcomes (1)
Cost of immunosuppressive medication
Overall cost of immunosuppressive medication during first year post kidney transplant
Measured: 1 year post kidney transplant+
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2018
- Study start21 Mar 2018
- Primary completion21 Mar 2022 (estimated)
- Study completion21 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Khartoum
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Kidney Diseases and Surgery
- Responsible party
- Principal investigator, Sarra Elamin, University of Khartoum
- Investigators
- Sarra Elamin, MD, Principal investigator, Consultant Nephrologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03789006
- Sponsor's protocol ID
- 033546
- Status last verified
- Dec 2018
- First submitted
- 25 Dec 2018
- Last updated
- 3 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Antithymocyte Globulin and Azathioprine Versus Basiliximab and Mycophenolate Mofetil When Used in Combination With Tacrolimus and Prednisolone in Living Donor Kidney Transplantation
- ClinicalTrials.gov ID
- NCT03789006
- Acronym / sponsor ID
- 033546
- Conditions
- Kidney Transplant Rejection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of KhartoumUniversity, hospital or other
- Collaborators
- National Center for Kidney Diseases and Surgery
- Study start
- 21 Mar 2018 (actual)
- Primary completion
- 21 Mar 2022 (estimated)
- Study completion
- 21 Mar 2024 (estimated)
- First posted
- 28 Dec 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.
Kidney transplantation is the best available treatment option for patients with end stage renal disease. However, kidney transplantation requires life-long use of immunosuppressive medication. Because of the high cost of these medications we need to carefully evaluate the cost-effectiveness of each drug regimen, especially in low-middle income countries. The objective of this clinical trial is to compare the efficiency and cost of two immunosuppressive protocols after living donor kidney transplantation: (1) antithymocyte globulin, tacrolimus, azathioprine and prednisolone versus (2) basiliximab, tacrolimus, mycophenolate mofetil and prednisolone.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| ATG | Active comparator | Drug: Antithymocyte Immunoglobulin (Rabbit)Induction with antithymocyte immunoglobulin (Rabbit) (Grafalon) and maintenance with tacrolimus, azathioprine and prednisolone |
| BAS | Active comparator | Drug: Interleukin 2 Receptor AntagonistInduction with interleukin 2 receptor antagonist (basiliximab) and maintenance with tacrolimus, mycophenolate mofetil and prednisolone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult end-stage renal disease patients
- First living donor kidney transplant.
- Moderate immunological risk.
Key exclusion criteria (3 listed)
- Low immunological risk (HLA mismatches 000/100/010/110 with negative PRA).
- High immunological risk (child to mother or husband to wife transplant, 2 DR mismatches).
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 |
|---|---|---|
| Antithymocyte Immunoglobulin (Rabbit)Also: grafalonInduction agent for living donor kidney transplantation | Drug | ATG |
| Interleukin 2 Receptor AntagonistAlso: BasiliximabInduction agent for living donor kidney transplantation | Drug | BAS |
Primary outcome
Incidence of acute rejection
Time frame: 6 months post kidney transplant
The incidence of acute rejection will include clinically diagnosed and biopsy proven acute rejection. Clinically diagnosed rejection includes at least 30% acute rise in serum creatinine level. Biopsy proven rejection will include both cellular and antibody mediated rejection according to Banff 2017 criteria
One year graft survival
Time frame: 1 year post kidney transplant
One year kidney allograft survival, uncensored for patient death
1 secondary outcome
Cost of immunosuppressive medication
Time frame: 1 year post kidney transplant+
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Kidney Transplant Rejection
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A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
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Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Pediatric Kidney Disease, Transplant;Failure,Kidney
Not yet recruitingPhase 2
(TNX-1500) in Kidney Transplant Recipients
Kidney Transplant, Kidney Transplant Failure and Rejection
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A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation
Microvascular Inflammation
Not yet recruitingObservational study
Assessment of Perceived Stress in an Observational Study Evaluating a Biopsy-sparing Surveillance Strategy in Kidney Transplant Recipients With Blood and Urinary Biomarkers Predictive of the Absence of Rejection
Renal Transplantation; Complication, Renal Transplant
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.
Sarra Elamin, MD principal investigator
Consultant Nephrologist
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 Antithymocyte Immunoglobulin (Rabbit) and Interleukin 2 Receptor Antagonist in people with Kidney Transplant Rejection, run by University of Khartoum at 1 site in Sudan.
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 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 Jan 2019. 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 Sudan. 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 Sarra Elamin, MD ((+249)912474666, sarraelamin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of acute rejection (time frame: 6 months post kidney transplant). The study lists 2 primary outcomes in all. 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 Jan 2019.