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Open Access Study protocol

KNOW-KT (KoreaN cohort study for outcome in patients with kidney transplantation: a 9-year longitudinal cohort study): study rationale and methodology

Jaeseok Yang1, Joongyup Lee2, Kyu Ha Huh3, Jae Berm Park4, Jang-Hee Cho5, Sik Lee6, Han Ro7, Seung-Yeup Han8, Young Hoon Kim9, Jong Cheol Jeong1, Byung-Joo Park102, Duck Jong Han9, Sung-Bae Park8, Wookyung Chung7, Sung Kwang Park6, Chan-Duck Kim5, Sung Joo Kim4, Yu Seun Kim3, Curie Ahn111* and KNOW-KT Study Group

Author Affiliations

1 Transplantation Center, Seoul National University Hospital, Seoul, Republic of Korea

2 Medical Research Collaborating Center, Seoul National University Hospital, Seoul, Republic of Korea

3 Department of Transplantation Surgery, Severance Hospital, Yonsei University Health System, Seoul, Republic of Korea

4 Department of Surgery, Sungkyunkwan University, Seoul Samsung Medical Center, Seoul, Republic of Korea

5 Department of Internal Medicine, Kyungpook National University Hospital, Seoul, Republic of Korea

6 Department of Internal Medicine, Chonbuk National University Hospital, Seoul, Republic of Korea

7 Department of Internal Medicine, Gachon University, Gil Hospital, Seoul, Republic of Korea

8 Department of Internal Medicine, Keimyung University, Dongsan Medical Center, Seoul, Republic of Korea

9 Department of Surgery, Ulsan University, Seoul Asan Medical Center, Seoul, Republic of Korea

10 Department of Preventive Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea

11 Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea

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BMC Nephrology 2014, 15:77  doi:10.1186/1471-2369-15-77

Published: 9 May 2014

Abstract

Background

Asian patients undergoing kidney transplantation (KT) generally have better renal allograft survival and a lower burden of cardiovascular disease than those of other racial groups. The KNOW-KT aims to explore allograft survival rate, cardiovascular events, and metabolic profiles and to elucidate the risk factors in Korean KT patients.

Methods

KNOW-KT is a multicenter, observational cohort study encompassing 8 transplant centers in the Republic of Korea. KNOW-KT will enroll 1,000 KT recipients between 2012 and 2015 and follow them up to 9 years. At the time of KT and at pre-specified intervals, clinical information, laboratory test results, and functional and imaging studies on cardiovascular disease and metabolic complications will be recorded. Comorbid status will be assessed by the age-adjusted Charlson co-morbidity index. Medication adherence and information on quality of life (QoL) will be monitored periodically. The QoL will be assessed by the Kidney Disease Quality of Life Short Form. Donors will include both living donors and deceased donors whose status will be assessed by the Kidney Donor Risk Index. Primary endpoints include graft loss and patient mortality. Secondary endpoints include renal functional deterioration (a decrease in eGFR to <30 mL/min/1.73 m2), acute rejection, cardiovascular event, albuminuria, new-onset diabetes after transplant, and QoL. Data on other adverse outcomes including episodes of infection, malignancy, recurrence of original renal disease, fracture, and hospitalization will also be collected. A bio-bank has been established for the acquisition of DNA, RNA, and protein from serum and urine samples of recipients at regular intervals. Bio-samples from donors will also be collected at the time of KT. KNOW-KT was registered in an international clinical trial registry (NCT02042963 at http://www.clinicaltrials.gov webcite) on January 20th, 2014.

Conclusion

The KNOW-KT, the first large-scale cohort study in Asian KT patients, is expected to represent the Asian KT population and provide information on their natural course, complications, and risk factors for complications.

Keywords:
Cohort study; Complication; Kidney transplantation; KNOW-KT; Risk factor