Blog: Dr Sejal Patel, Physician, Researcher and Kidney Transplant Patient
By Jim Myers
Introduction
On Friday, January 14th, 2022, I did a remarkably broadcast with Sejal Patel, M.D., CCRP. https://m.facebook.com/story.php?story_fbid=497914464999895&id=100043440381744.
Dr. Patel is a Certified Clinical Research Coordinator, Kidney Researcher, Pre-Emptive Kidney/Pancreas Transplant Patient and a remarkably generous medical professional.
Our original conversation was scheduled to take place on November 5th, 2021, but on November 4th, 2021, Sajel had her second kidney transplant. We rescheduled our talk.
She is a graduate of the Medical University of Silesia in Poland, she is Board Certified through the ECFMG, (Educational Comission for Foreign Medical Graduates) and the Accreditation Counsel for Graduate Medical Education. Sejal is also a Clinical Research Professional (CCRP) and a Certified Member of the SoCRA, the Society of Clinical Research Associates.
She is currently employed with the Clinical Research Studies Unit at the Mayo Clinic in Arizona, where she is working on projects like Kidney Research with a Kidney Transplant Group, Increasing Antibodies with the Kidney Transplant Population vs COVID-19, as well as Studies concerning Kidney Transplant that last for a lifetime by preventing rejection, Taking Kidney Transplant Patients off of immunosuppressive medications by injecting donor stem cells,& discovering meds to lower antibodies so people can be transplanted that have a high level of antigens.
She has 8+ years of clinical and research experience with the Mayo Clinic Clinical Studies Unit/Multi-Disciplinary Transplant Research Team as a Certified Clinical Research Studies since November of 2019, in the areas of Psychiatry, Pediatric Solid and Liquid Tumors, Rare disease, Solid Organ and Bone Marrow Transplant Medicine, Diabetes, Immunology, Infectious Disease, Orthopedics, Transfusion medicine, Transplantation, Gastroenterology, Rheumatology, Cosmetic Science, Dermatology, and Ophthalmology.
She recently received a promotion to Senior Research Program Coordinator.
We were very fortunate to have her on the Broadcast and to have the benefit of her unequaled expertise.
https://www.blogger.com/blog/post/edit/1185533682031565831/8345240592456927359
Experiences As A Kidney Patient
Dr. Patel is not only a remarkable researcher, but a kidney patient as well! When she was 10/11, she was first diagnosed with Type 1 Diabetes which may have resulted from an Autoimmune Disease/Malaria she acquired at the age of 9 while visiting India.
She lived unremarkably with Type 1 Diabetes through medical school and her residency rotations. when suddenly she began to feel weak and dizzy. She became anemic. After many doctor visits and iron infusions, her condition did not improve.
After a visit with her Endrocronologist and her normal 3 month check up, she learned that her creatinine had jumped to 2.5. The typical range for serum creatinine for adult women, is 0.59 to 1.04 mg/dL (52.2 to 91.9 micromoles/L).
https://www.mayoclinic.org/tests-procedures/creatinine-test/about/pac-20384646.
Her doctor then ordered a biopsy where it was discovered that she was in Stage 5 Kidney Failure secondary to Stage 1 Diabetes! She was immediately referred to the Mayo Clinic in Arizona for a preemptive kidney/pancreas transplant.
What Is A Pre-Emptive Kidney Transplant?
A preemptive kidney transplant is when you receive a kidney transplant before your kidney function deteriorates to the point of needing dialysis to replace the normal filtering function of the kidneys.
https://www.mayoclinic.org/tests-procedures/preemptive-kidney-transplant/pyc-20384830
See Also: Preemptive Kidney Transplants: Why Aren't They More Popular? https://www.kidney.org/newsletter/preemptive-kidney-transplants.
Qualifications For A Kidney Pancreas Transplant
A Kidney/Pancreas Transplant had some special requirements that Sejal had to overcome.
The requirements for a Kidney/ Pancreas Transplant are:
In order to accrue KP waiting time, a KP candidate must be 18 years or older, and:
• Be registered for a kidney‐pancreas transplant
• Qualify for kidney waiting time
• Meet one of the following criteria:
• Is on insulin and has a C‐peptide value less than or equal to 2 ng/mL
• Is on insulin and has a C‐peptide value greater than 2 ng/mL and has a body mass index less (BMI) than or equal to the maximum allowable BMI.
https://optn.transplant.hrsa.gov/professionals/by-topic/guidance/kidney-pancreas-allocation-system-frequently-asked-questions/
Pancreas Transplants, https://www.mayoclinic.org/tests-procedures/pancreas-transplant/about/pac-20384783
Kidney-Pancreas Transplant, https://www.kidney.org/atoz/content/kidpantx.
Fortunately, Sejal met the criteria, and was listed a week after applying.
1st Kidney Transplant
Fortunately, Dr. Patel was transplanted at the Mayo Clinic in Arizona in November of 2009. The transplant went off without a hitch and Sejal was doing very well. The results as far as her new kidney and pancreas were concerned were initially very good. Sejal called it, "...the greatest thing ever," because it cured her diabetes while saving her kidney function.
Kent's Kidney Stories, Episode 81: Sejal Patel Needs A Kidney Donor. Are YOU The One? https://youtu.be/-NXrZPm6Ubo. This Kidney Transplant would last her about 12 years.
Complications and Challenges to First Kidney Transplant
In 2021, Sejal's kidney began to get weaker, causing her to become listed again for a kidney transplant. She contracted Valley Fever in January of 2021, causing her to start dialysis, with a creatinine level of 12.
"Valley fever, also called coccidioidomycosis, is an infection caused by the fungus Coccidioides. The fungus is known to live in the soil in the southwestern United States and parts of Mexico and Central and South America. The fungus was also recently found in south-central Washington. People can get Valley fever by breathing in the microscopic fungal spores from the air, although most people who breathe in the spores don’t get sick. Usually, people who get sick with Valley fever will get better on their own within weeks to months, but some people will need antifungal medication. Certain groups of people are at higher risk for becoming severely ill. It’s difficult to prevent exposure to Coccidioides in areas where it’s common in the environment, but people who are at higher risk for severe Valley fever should try to avoid breathing in large amounts of dust if they’re in these areas."
https://www.cdc.gov/fungal/diseases/coccidioidomycosis/index.html
Amount the people considered to be at higher risk are people with solid organ transplants, like your kidneys.
See Also: https://www.mayoclinic.org/diseases-conditions/valley-fever/symptoms-causes/syc-20378761
"Renal impairment is a frequent occurrence among patients with the Rift Valley fever (RVF), and is probably the result of hypovolemia and multiple organ dysfunctions in the majority of cases."
Acute renal failure associated with the Rift Valley fever: a single center study
https://pubmed.ncbi.nlm.nih.gov/19861868/
2d Kidney Transplant
Sejal had her second kidney transplant at Mayos Arizona on November 4th, 2021. This transplant was from a deceased donor, who suffered from Acute Kidney Injury, and therefore would require a little dialysis after transplant to get the kidney to wake up and function properly. After the transplant, she did have dialysis with a catheter 5 times. Her creatinine level has improved to 1.2. Two weeks ago, she returned to work.
Professional Studies Experiences
Dr. Patel spoke to us about several of the on-going studies she is involved with:
Freedom-1 Study – Talaris (Active):
The goal of this study is with living kidney transplants, to eliminate the use of immunosuppressive medications after 1 yr of transplant. It will require the donor to donate stem cells.
Freedom-1 Clinical Trial for Kidney Transplant Patients
https://youtu.be/SxJhxrfxOd8
This is a research study to test a new investigational product called FCR001, a stem cell-based product that comes from cells collected from the kidney donor’s blood and is infused into a kidney transplant recipient who has been assigned to receive FCR001. Primary objective is to evaluate the proportion of FCR001 recipients (FCR-R) who are free from IS, (immunosuppressive medications) without biopsy-proven acute rejection (BPAR), at 24 months post-transplant.
This is a new study of an experimental medication, designed to prevent rejection in kidney transplant recipients.
Antibody Mediated Rejection (AMR) Study – Hansa (Active):
The aims of treatment are to preserve renal function, reduce histological injury, and reduce the titer of donor-specific antibody (To prevent kidney rejection after transplant)
The purpose of this research is to learn if an experimental drug, imlifidase, is better at treating kidney graft rejection caused by antibodies than the standard of care treatment, plasma exchange. The primary endpoint of this study is: Maximum reduction in mean DSA levels at any time point during the 5 days following the start of treatment.
• A Randomized, Open-Label, Multi-Centre, Active Control Study Investigating the Efficacy and Safety of Imlifidase in Eliminating Donor Specific Anti-HLA Antibodies in the Treatment of Active Antibody-Mediated Rejection in Kidney Transplant Patients
An Efficacy and Safety Study of Imlifidase in Treatment of Antibody-Mediated Rejection in Kidney Transplant Patients
https://clinicaltrials.gov/ct2/show/NCT03897205;
Recommended Treatment for Antibody-mediated Rejection After Kidney Transplantation: The 2019 Expert Consensus From the Transplantion Society Working Group
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7176344/
• SIMPLE study- The purpose of this research is to learn if taking once a day tacrolimus extended release (Envarsus XR®) increases medication compliance, reduces transplant and medication side effects, and increases quality of life, as compared to tacrolimus twice daily immediate release
(The affect of lowering the dosage of Tacrolimus to 1x/day)
• A Prospective, Observational, Multicenter, Open-Label, Pilot Study to Investigate Medication Adherence and Patient Reported Symptom Occurrence and Interference with Daily Life Comparing Once-Daily Envarsus XR® and Twice-Daily Immediate Release Tacrolimus in Adult Renal Transplant Recipients
This study is completed for enrollment and we are just in follow up phase with the patients and completing data entry so we can look at the outcome when all the information is completed.
A Simple Novel Technique to Estimate Tacrolimus Dosages During the Early Post Kidney Transplantation Period
https://pubmed.ncbi.nlm.nih.gov/26518946/;
Envarsus XR Compared to Immediate Release Tacrolimus (SIMPLE)
https://clinicaltrials.gov/ct2/show/NCT03979365;
Imagine Study -
(To Prevent Kidney Transplant Rejection in diseases like FSGS)
This study is being carried out to see if the investigational product C1-esterase inhibitor (C1- INH) is effective in treating AMR, and if so, how it compares with the standard treatment. C1- INH is a natural protein found in your blood, and it helps control the immune system. A C1- INH medication called Berinert has been approved for patients who are missing the protein and have an inherited disease called hereditary angioedema (HAE).
A Double-blind, Randomized-withdrawal, Placebo-controlled Study to Evaluate the Efficacy and Safety of Human Plasma-derived C1-esterase Inhibitor as add-on to Standard of Care for the Treatment of Refractory Antibody Mediated Rejection in Adult Renal Transplant Recipients
Antibody-Mediated Rejection: A Review
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5349636/;
Recommended Treatment for Antibody-mediated Rejection After Kidney Transplantation: The 2019 Expert Consensus From the Transplantion Society Working Group
https://journals.lww.com/transplantjournal/fulltext/2020/05000/recommended_treatment_for_antibody_mediated.11.aspx;
Efficacy and Safety of Human Plasma-derived C1-esterase Inhibitor as add-on to Standard of Care for the Treatment of Refractory Antibody Mediated Rejection (AMR) in Adult Renal Transplant Recipients
https://clinicaltrials.gov/ct2/show/NCT03221842;
The Role of Genetics and Socioeconomic Factors in Outcomes After Kidney Transplantation in Hispanics and American Indians
The purpose of this research is to develop tools to assess socioeconomic risk factors and to identify genes associated with transplant outcomes in Hispanics and American Indians. A better understanding of these factors will help guide management and improve future outcomes.
Ethnic advantages in kidney transplant outcomes: the Hispanic Paradox at work?
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2721429/;
Association of Race and Ethnicity With Live Donor Kidney Transplantation in the United States From 1995 to 2014
https://jamanetwork.com/journals/jama/fullarticle/2667722.
She hopes that the news of the studies, "reaches transplant patients that may be interested and they can reach out to mayo if it helps any of them."
When I asked Dr. Patel why she does research work, she answered, "We're hoping to find better treatment, I really like the fact that we are hoping to improve their [Kidney Patients] lives."
Future Projects
Dr. Patel did mention one future project that is in the works dealing with COVID-19 and the Kidney Transplant Population. Some kidney transplant patients on immunosuppressive medications, despite taking the vaccine are not getting sufficient antibodies to ward off the COVID-19 variants. One study is about what must be done so transplant patients on immunosuppressants can develop the necessary antibodies to protect them from the virus.
Dr. Patel noted that the study is NOT ready to go yet, and members of the public cannot apply at this time.
She also hopes that new studies in cardiovascular issues will be helpful to patients under her new responsibilities.
Conclusion
Dr. Patel was very candid about her Kidney Story from diagnosis to kidney transplant. Her insights into her work were particularly insightful. This was a special conversation from a special physician and Kidney Patient!
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