Stanford Surgery Clinical Trials

Transformative Research in Diabetic Nephropathy

This is a prospective, observational, cohort study of patients with a clinical diagnosis of diabetes who are undergoing clinically indicated kidney biopsy. The intent is to collect, process, and study kidney tissue and to harvest blood, urine and genetic materials to elucidate molecular pathways and link them to biomarkers that characterize those patients have a rapid decline in kidney function (> 5 mL/min/1.73m2/year) from those with lesser degrees of kidney function change over the period of observation. High through-put genomic analysis associated with genetic and biomarker testing will serve to identify key potential therapeutic targets for DKD by comparing patients with rapid and slow progression patterns. Each participating clinical site will search for, consent, harvest the biopsy sample, and enroll the participants as required for the TRIDENT protocol.

Stanford is currently accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • other: There is no intervention

Eligibility


Inclusion Criteria:

   - Type 1 and 2 Diabetes by American Diabetes Association (ADA) criteria

   - Willingness to comply with study requirements, including intention to fully
   participate in protocol-specified follow-up at a clinical study site

   - Able to provide informed consent

   - Adult participants

   - Planned medically indicated kidney biopsy, prescribed by a practicing nephrologist

Exclusion Criteria:

   - End Stage Renal Disease (ESRD), defined as chronic dialysis or kidney transplant

   - History of receiving dialysis for more than 30 days prior to biopsy

   - Institutionalized

   - Solid organ or bone marrow transplant recipient at time of first kidney biopsy

   - Less than 3-year life expectancy

   - History of active alcohol and/or substance abuse that in the investigator's assessment
   would impair the subject's ability to comply with the protocol

   - Unable to provide informed consent

   - Evidence of active cancer requiring treatment, other than non-melanoma skin cancer

Ages Eligible for Study

18 Years - 100 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Shiktj Dave
650-723-2240
I'm interested

Transplantation

Transformative Research in Diabetic Nephropathy

This is a prospective, observational, cohort study of patients with a clinical diagnosis of diabetes who are undergoing clinically indicated kidney biopsy. The intent is to collect, process, and study kidney tissue and to harvest blood, urine and genetic materials to elucidate molecular pathways and link them to biomarkers that characterize those patients have a rapid decline in kidney function (> 5 mL/min/1.73m2/year) from those with lesser degrees of kidney function change over the period of observation. High through-put genomic analysis associated with genetic and biomarker testing will serve to identify key potential therapeutic targets for DKD by comparing patients with rapid and slow progression patterns. Each participating clinical site will search for, consent, harvest the biopsy sample, and enroll the participants as required for the TRIDENT protocol.

Stanford is currently accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • other: There is no intervention

Eligibility


Inclusion Criteria:

   - Type 1 and 2 Diabetes by American Diabetes Association (ADA) criteria

   - Willingness to comply with study requirements, including intention to fully
   participate in protocol-specified follow-up at a clinical study site

   - Able to provide informed consent

   - Adult participants

   - Planned medically indicated kidney biopsy, prescribed by a practicing nephrologist

Exclusion Criteria:

   - End Stage Renal Disease (ESRD), defined as chronic dialysis or kidney transplant

   - History of receiving dialysis for more than 30 days prior to biopsy

   - Institutionalized

   - Solid organ or bone marrow transplant recipient at time of first kidney biopsy

   - Less than 3-year life expectancy

   - History of active alcohol and/or substance abuse that in the investigator's assessment
   would impair the subject's ability to comply with the protocol

   - Unable to provide informed consent

   - Evidence of active cancer requiring treatment, other than non-melanoma skin cancer

Ages Eligible for Study

18 Years - 100 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Shiktj Dave
650-723-2240
I'm interested

Surgery

Transformative Research in Diabetic Nephropathy

This is a prospective, observational, cohort study of patients with a clinical diagnosis of diabetes who are undergoing clinically indicated kidney biopsy. The intent is to collect, process, and study kidney tissue and to harvest blood, urine and genetic materials to elucidate molecular pathways and link them to biomarkers that characterize those patients have a rapid decline in kidney function (> 5 mL/min/1.73m2/year) from those with lesser degrees of kidney function change over the period of observation. High through-put genomic analysis associated with genetic and biomarker testing will serve to identify key potential therapeutic targets for DKD by comparing patients with rapid and slow progression patterns. Each participating clinical site will search for, consent, harvest the biopsy sample, and enroll the participants as required for the TRIDENT protocol.

Stanford is currently accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • other: There is no intervention

Eligibility


Inclusion Criteria:

   - Type 1 and 2 Diabetes by American Diabetes Association (ADA) criteria

   - Willingness to comply with study requirements, including intention to fully
   participate in protocol-specified follow-up at a clinical study site

   - Able to provide informed consent

   - Adult participants

   - Planned medically indicated kidney biopsy, prescribed by a practicing nephrologist

Exclusion Criteria:

   - End Stage Renal Disease (ESRD), defined as chronic dialysis or kidney transplant

   - History of receiving dialysis for more than 30 days prior to biopsy

   - Institutionalized

   - Solid organ or bone marrow transplant recipient at time of first kidney biopsy

   - Less than 3-year life expectancy

   - History of active alcohol and/or substance abuse that in the investigator's assessment
   would impair the subject's ability to comply with the protocol

   - Unable to provide informed consent

   - Evidence of active cancer requiring treatment, other than non-melanoma skin cancer

Ages Eligible for Study

18 Years - 100 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Shiktj Dave
650-723-2240
I'm interested