Process for Living Donor Kidney Transplantation

Living Donor kidney transplantation (LDKT) is unique, as it requires ensuring the health of both the donor and the recipient while ruling out contraindications for kidney transplantation. Therefore, preoperative evaluations must be comprehensive and meticulous.

（一）Donor Evaluation

Protecting the health of the donor is the fundamental ethical principle of LDKT and takes precedence over that of the recipient. Donors must undergo a thorough health assessment. If significant health issues are identified, they will be deemed unsuitable for donation. Given the extensive list of preoperative tests, evaluations should be conducted in a stepwise manner, progressing from simple to complex and from low-cost to high-cost tests. If health issues are detected at any stage, further testing will be discontinued.

⑴ Initial Screening

① Blood type, complete blood count (CBC), liver and kidney function, electrolytes, ion concentrations, lipid profile, fasting blood glucose, urinalysis (with 24-hour urine protein quantification if proteinuria is detected);

② Ultrasound: thyroid, liver, gallbladder, pancreas, spleen, kidneys + ureters, bladder, adrenal glands, retroperitoneum, prostate and scrotal contents (for males), breast, uterus, and adnexa (for females).

⑵ Further Tests

① Laboratory tests: blood type confirmation (at two hospitals, including ours, as per policy), coagulation profile, pre-transfusion panel (HBV DNA for those with hepatitis B history, HCV RNA for those with hepatitis C history), erythrocyte sedimentation rate (ESR), T-cell spot test for tuberculosis (T-spot), parathyroid hormone (PTH), cytomegalovirus (CMV) IgG and IgM;

② Tumor markers: PSA + fPSA (for males ≥50 years old), AFP, CEA, CA199, CA724, NSE, CA125, CA153 (for females);

③ Cervical cytology test (TCT) (for females ≥40 years old);

④ Imaging studies: electrocardiogram (ECG), chest CT (plain scan).

⑶ Final Tests

HLA typing, radionuclide renal scan, renal vascular CT (CTA, CTV).

（二）Recipient Evaluation for Kidney Transplantation

Recipients of living donor kidney transplants and DCD kidneys undergo the same comprehensive medical assessments to rule out contraindications for kidney transplantation. The evaluation includes:

① Routine Laboratory TestsCBC, liver and kidney function, electrolytes, ion concentrations, fasting blood glucose, lipid profile, blood type confirmation (at our hospital and one other), coagulation profile, pre-transfusion panel, ESR, T-spot, PTH, lymphocyte typing, cytokines.

② Virology Tests：HBV DNA (for hepatitis B patients), HCV RNA (for hepatitis C patients), CMV antibodies, rubella virus antibodies, toxoplasma antibodies, EB virus antibodies, BK virus nucleic acid quantification (blood and urine).

③Tumor-Related Tests：PSA + fPSA (for males ≥50 years old), AFP, CEA, CA199, CA724, NSE, CA125, CA153 (for females), cervical cytology test (TCT, for females ≥40 years old).

④Imaging Studies：ECG, chest CT (plain scan), ultrasound (thyroid, liver, gallbladder, pancreas, spleen, kidneys, ureters, adrenal glands, retroperitoneum, breast, uterus, and adnexa for females, scrotal contents and prostate for males), vascular ultrasound (iliac artery and vein), echocardiography.

⑤Tissue Typing：HLA typing, panel reactive antibodies (PRA), lymphocytotoxicity test.

After completing the above evaluations, if the donor is found to be healthy and the recipient has no contraindications for kidney transplantation, the next stage of LDKT preparation can proceed: the ethical review and preparation phase.

（三）Ethical Preparation

Living donor kidney transplantation must undergo rigorous ethical approval. According to China’s Regulations on Human Organ Transplantation, living organ donors must be citizens aged 18 years or older. Recipients of living organ donations are limited to the donor’s spouse, direct blood relatives, or collateral blood relatives within three generations.

The ethical documentation and approval process for living-related kidney transplantation at the Department of Kidney Transplantation, Zhongshan Hospital Affiliated to Fudan University, are as follows:

1.Photocopies of Identity Cards  

Photocopies of the identity cards of the donor (donor), the donor’s father and mother (biological parents), the donor’s spouse, and all children of the donor (hereinafter referred to as “donor and related parties”). Photocopies of identity cards for minor children of the donor are not required. Photocopies of the recipient’s identity card (both sides). If the identity card is lost, a population information certificate must be issued by the local public security authority.

2. Proof of Relationship  

Photocopies of the household registration books of the donor and related parties and the recipient, including the front page of the household registration book.

3. Household Registration Certificates and Requirements for Donor and Related Parties and Recipient  

①Must be issued by the local public security authority. Relationship certificates issued by neighborhood committees or village committees will not be accepted.  

② The household registration certificate must include the name and ID number of the person being certified.

③The certificate must specify the relationship between the donor and the recipient, the parent-child relationship between the donor and his/her parents, the marital relationship between the donor and his/her spouse, and the parent-child relationship between the donor and all his/her children.  

④The certificate must be printed or photocopied, not handwritten, and must bear the official seal of the local public security authority (police station). The header should generally be “Household Registration Certificate” (subject to local police station regulations). The certificate must be signed by the handling officer, accompanied by a contact phone number and date, as the health commission will contact the officer to verify the authenticity of the certificate.  

⑤ If the donor’s parents have passed away, a death certificate can be obtained from the neighborhood or village committee, specifying the relationship between the donor (name, ID number) and his/her parents (names) and the time of death. The certificate should bear the seal of the neighborhood or village committee and can be handwritten.  

⑥ For spousal kidney transplantation, a copy of the marriage certificate is required.  

⑦ If the donor and related parties are in the same household registration book (donor and recipient are not separated), the household registration book can be photocopied, with the police station’s seal, officer’s signature, and contact phone number. For related parties not in the same household registration book as the donor or recipient, a household registration certificate must be issued according to the above requirements 3 and 4.

4. 2-inch Individual Passport Photos：One 2-inch individual passport photo for both the donor and the recipient.  

5. Blood Type and Tissue Typing Reports  ：Blood type reports for both the donor and recipient from the Blood Transfusion Department of Zhongshan Hospital. HLA, PRA, and CDC reports issued by the Tissue Typing Laboratory of Zhongshan Hospital.

6. Required Medical Test Reports for Donor and Recipient  

Donor: Complete blood count (CBC), urinalysis, liver and kidney function, coagulation profile, fasting blood glucose, lipid profile, hepatitis B panel, hepatitis C antibody, HIV antibody, RPR, electrocardiogram (ECG), chest X-ray, abdominal ultrasound, CTA, ECT, and report height and weight.  

Recipient: Recent CBC, liver and kidney function, coagulation profile, hepatitis B panel, hepatitis C antibody, HIV antibody, RPR reports.

After all the required documents are prepared, the donor and recipient should bring the above documents, along with the original identity cards, household registration books, and marriage certificate (for spousal donation) of all related parties, to Room 709, 7th Floor, Building 1, Zhongshan Hospital Affiliated to Fudan University, every Tuesday from 2:00 PM to 4:00 PM to complete the procedures.

Once the documents are reviewed and found to be correct, the following steps must be completed: signing the intention letter and informed consent form, and electronic chip verification of the original identity cards of the donor, related parties, and recipient.

After completing these steps, all documents will be submitted to the Zhongshan Hospital Ethics Committee for review. The committee will hold regular meetings to conduct the review. At that time, the donor, related parties, and recipient will be required to attend an interview. Subsequently, the hospital will submit all documents to the Shanghai Municipal Health Commission’s Medical Management Department for further review. Upon approval, the Medical Management Department will send the approval letter back to our hospital, and the donor and recipient can then wait for the notification to be admitted for surgery.

Note: The above items may vary depending on the patient’s medical history.