Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03789006
Other study ID # 033546
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date March 21, 2018
Est. completion date March 21, 2024

Study information

Verified date December 2018
Source University of Khartoum
Contact Sarra Elamin, MD
Phone (+249)912474666
Email sarraelamin@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date March 21, 2024
Est. primary completion date March 21, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adult end-stage renal disease patients

- First living donor kidney transplant.

- Moderate immunological risk.

Exclusion Criteria:

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Antithymocyte Immunoglobulin (Rabbit)
Induction agent for living donor kidney transplantation
Interleukin 2 Receptor Antagonist
Induction agent for living donor kidney transplantation

Locations

Country Name City State
Sudan Doctor Salma Center for Kidney Diseases Khartoum

Sponsors (2)

Lead Sponsor Collaborator
University of Khartoum National Center for Kidney Diseases and Surgery

Country where clinical trial is conducted

Sudan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 6 months post kidney transplant
Primary One year graft survival One year kidney allograft survival, uncensored for patient death 1 year post kidney transplant
Secondary Cost of immunosuppressive medication Overall cost of immunosuppressive medication during first year post kidney transplant 1 year post kidney transplant+
See also
  Status Clinical Trial Phase
Recruiting NCT04491552 - TruGraf® Long-term Clinical Outcomes Study
Withdrawn NCT04560582 - Immunosuppression Reduction in Failed Allograft Guided by cfDNA
Completed NCT05747274 - SRDK0921_ Analytical Performance Study
Not yet recruiting NCT05482100 - CLinical Utility of the omnigrAf® biomarkeR Panel In The Care of kidneY Transplant Recipients
Recruiting NCT06243289 - Improving KIdney Transplantation With Cellular Therapy Study
Not yet recruiting NCT06025240 - Expanding the Scope of Post-transplant HLA-specific Antibody Detection and Monitoring in Renal Transplant Recipients
Completed NCT04367610 - Effects of A Standardized Treatment Approach on Kidney Transplant Recipients With Antibody-Mediated Rejection
Enrolling by invitation NCT06126380 - Long-Term Safety and Efficacy of Tegoprubart in Kidney Transplant Recipients Phase 2
Terminated NCT05747053 - Personalization of Immunosuppressive Treatment for Organ Transplant Recipients
Active, not recruiting NCT03714113 - Donor-specific Anti-HLA Antibodies Monitoring in Kidney Transplant Recipients N/A
Recruiting NCT04091984 - The PROspera Kidney Transplant ACTIVE Rejection Assessment Registry (ProActive)
Recruiting NCT05335538 - TruGraf and TRAC In Pediatrics Study
Completed NCT03663335 - Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Kidney Transplant Recipients Phase 2
Completed NCT03652402 - Precision Risk Stratification in Kidney Transplant Patients - EU-TRAIN
Recruiting NCT04773392 - Simplified IMmunosuppressive Protocol Utilizing Low Dose EnvarsusXR Phase 4
Terminated NCT02974686 - Conversion From MPA to Zortress (Everolimus) for GI Toxicity Post-renal Transplantation Phase 4
Completed NCT03873623 - The TOGETHER Project - Kidney
Terminated NCT04156204 - Immunosuppressant Medication Dosed Daily After Kidney Transplant Early Phase 1
Completed NCT04601155 - Transition of Renal Patients Using AlloSure Into Community Kidney Care
Completed NCT03874299 - The TOGETHER Project - Kidney RNA-seq Validation