Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03968588
Other study ID # 062KTP14-1C
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date July 29, 2014
Est. completion date June 14, 2017

Study information

Verified date May 2019
Source Ajou University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A prospective, multicenter, open-label, randomized and parallel-group clinical trial was conducted at four transplant centers in Korea. This clinical study was designed to compare the efficacy and tolerability of reduced-dose tacrolimus with standard-dose mycophenolate mofetil (MMF) versus standard-dose tacrolimus with reduced-dose MMF.


Description:

A prospective, multicenter, open-label, randomized and parallel-group clinical trial was conducted at four transplant centers in Korea. The total sample size was 108 and eligible patients were randomly assigned in a 1:1 ratio to either study or control group. For six months study period, graft function, the incidence of efficacy failure and adverse events were compared.

The total sample size was 108 and eligible patients were randomly assigned in a 1:1 ratio to either study or control group: The study group (reduced-dose tacrolimus + standard-dose MMF) or the control group (standard-dose tacrolimus + reduced-dose MMF). Restricted block randomization was applied to this study and both the enrolled subjects and care providers were blinded until randomization was done. A difference in the mean estimated glomerular filtration rates (eGFR) of 16 mL/min/1.73m2 was considered a clinically meaningful margin of non-inferiority. A sample size of 108 for both groups was calculated for the primary endpoint by assuming a significance level of 0.025 with a power of at least 95% and adjusted for a potential dropout rate of 20%.

The primary efficacy endpoint was the renal graft function assessed with eGFR by MDRD formula at 6 months post-transplant. The secondary endpoints included (1) the incidence of treatment failure that included biopsy-confirmed acute rejection (BCAR), graft loss, death, or loss to follow-up until 6 months post-transplant; (2) recipients and grafts' survival rates; (3) 24-hour urine proteinuria and creatinine clearance at 6 months post-transplant. Recipients with clinical findings suggestive of acute rejection underwent biopsies before initiation or within 48 hours of anti-rejection therapy and biopsy specimens were graded according to Banff Classification criteria.

Safety endpoints included (1) all adverse event defined as any medical occurrence including worsening of a preexisting medical condition; (2) opportunistic infections; (3) malignancies; (4) abnormal laboratory findings; and (5) any abnormal physical findings or vital signs. Severe adverse events were defined as any adverse events with undesirable signs, symptoms, or medical conditions that met any one of the following criteria: 1) was fatal or life-threatening, 2) resulted in persistent or significant disability/incapacity, 3) required hospitalization or the prolongation of existing hospitalization, 4) was a congenital anomaly/birth defect, or 5) was an important medical event that might deteriorate the patient and require medical or surgical intervention to prevent one of the other outcomes listed above.18 All adverse events were coding using WHOART 2009 version.


Recruitment information / eligibility

Status Completed
Enrollment 108
Est. completion date June 14, 2017
Est. primary completion date November 11, 2016
Accepts healthy volunteers No
Gender All
Age group 20 Years to 65 Years
Eligibility Inclusion Criteria:

- Recipients (aged 20-65) of a single (first or second) renal allograft from living or deceased donor.

Exclusion Criteria:

- comprised of recipients with multiple organ transplants

- double kidney transplant or organs donated after cardiac death

- recipients previously organ transplanted except kidney

- ABO-incompatible transplants

- recipients with antibodies against the human leukocyte antigens of the donor organ

- history of malignancy in the previous 5 years (except successfully treated localized non-melanoma skin cancer and thyroid cancer)

- leukocyte counts of less than 2,500 per µL, or neutrophils less than 1,500 per µL, or platelets less than 50,000 per µL

- evidence of active systemic infection requiring the use of antibiotics, human immunodeficiency virus infection, or chronic active hepatitis B or C

Study Design


Related Conditions & MeSH terms

  • Disorder Related to Renal Transplantation

Intervention

Drug:
Tacrolimus(reduced), Mycophenolate mofetil(standard)
tacrolimus target trough blood level: 3~8ng/mL MMF dose: 1.5~2g/d
Tacrolimus(standard), Mycophenolate mofetil(reduced)
tacrolimus target trough blood level: 5~15ng/mL MMF dose: 0.5~1g/d

Locations

Country Name City State
Korea, Republic of Chonbuk National University Hospital Jeonju
Korea, Republic of Gangnam Severance Hospital Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Ajou University Hospital Suwon

Sponsors (1)

Lead Sponsor Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary renal graft function assessed with eGFR by MDRD formula 6 months post-transplant
Secondary incidence of treatment failure biopsy-confirmed acute rejection (BCAR), graft loss, death, or loss 6 months post-transplant
Secondary recipients and grafts' survival rates recipients and grafts' survival rates 6 months post-transplant
Secondary 24-hour urine proteinuria and creatinine clearance 24-hour urine proteinuria and creatinine clearance 6 months post-transplant
See also
  Status Clinical Trial Phase
Completed NCT02581436 - Testing Immunosuppression Threshold in Renal Allografts To Extend eGFR N/A
Terminated NCT01561404 - Effect of the Inhibition of the Mammalian Target of Rapamycin on Metabolism and Exercise Phase 4
Recruiting NCT02849899 - Prevention of Diabetes After Transplantation by Vildagliptin in the Early Post-transplant Period Phase 3
Not yet recruiting NCT01289301 - Studying the Effect of Changing Immunosuppression in Case of Polyoma BK Virus Infection of the Renal Transplant Phase 4
Completed NCT00905957 - Transversus Abdominis Plane Block For Renal Transplant Recipients N/A
Active, not recruiting NCT02843867 - Orientation of the Lymphocyte Response to the Occurrence of Atherosclerotic Complications After Kidney Transplantation
Active, not recruiting NCT02751099 - Bone and Cardiovascular Disease After Kidney Transplant
Completed NCT01744067 - The Effects of Omega-3 Fatty Acids in Renal Transplantation Phase 4
Completed NCT01646099 - Sun Protection of Kidney Transplant Recipients N/A
Active, not recruiting NCT03935958 - Curcumin in Kidney Transplant Recipients N/A
Recruiting NCT02513602 - Osseointegrated Dental Implants in Kidney Transplanted Patients N/A
Completed NCT01844713 - Evaluation of Sun Protection Education for Kidney Transplant Recipients N/A
Recruiting NCT01550445 - Steroid Withdrawal Immunosuppression After Renal Transplantation Phase 4
Completed NCT02540395 - Prospective Donor Specific T Response Measurment for IS Minimization in de Novo Renal Transplantation N/A
Completed NCT01195194 - Selection of Immunosuppression in Kidney Transplant Recipients Depending on Pre-transplant Donor-specific T-cell Reactivity. Phase 4
Completed NCT00724022 - Phase IV Study to Evaluate Calcineurin Inhibitor Reduced, Steroid Free Immunosuppression After Renal Transplantation Phase 4
Terminated NCT00167661 - Campath-1H Induction to Allow Steroid Free Immunosuppression in Pediatric Renal Transplantation Phase 1/Phase 2
Recruiting NCT02515643 - Contribution of Renal Function to Endothelial Dysfunction in Living Kidney Donors and Transplant Recipients N/A
Completed NCT00455013 - A Phase II Study of Belatacept (BMS-224818) With a Steroid-free Regimen in Subjects Undergoing Kidney Transplantation Phase 2
Recruiting NCT02843763 - Study of Specific CD4 Tumors Th1 Responses in Renal Transplant After Occurrence of Cancer N/A