A Study to Investigate the Impact of Pregnancy on Glomerular Filtrate Rate (GFR) Outcomes in Females with Primary Hyperoxaluria (PH)


About this study

The primary purpose of this study is to identify women with Primary Hyperoxaluria (PH) who have had pregnancies from a large, international registry and describe the maternal and fetal complications of pregnancies in this cohort, as well as compare outcomes of pregnancies before and after organ transplantation in women with PH.


Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Female with age ≥ 20 years.
  • Liver biopsy documenting AGT activity below the normal reference range confirming PH1 OR Liver biopsy documenting GR/HPR activity below the normal reference range confirming PH2.
  • Molecular genetic analysis (DNA testing) confirming a mutation known to cause PH1, PH2, or PH3; Homozygosity or compound heterozygosity of mutations of AGXT, GRHPR, or HOGA1 genes.
  • Urinary oxalate excretion of greater than 0.8 mmol/1.73 m2/day (>70 mg/1.73 m2/day) in the absence of a gastrointestinal disease known to cause hyperoxaluria (enteric hyperoxaluria).
  • If the patient presented in end stage renal failure, and neither a liver biopsy or mutational analysis were obtained, 5a and 5b must be fulfilled along with at least one of the criteria in 5c.
  • Pre-dialysis plasma oxalate greater than 60 µmol/L; AND
  • Renal biopsy confirming extensive oxalate deposition.
  • Evidence of systemic oxalosis (at least one of the following criteria):
    • retinal oxalate deposits;
    • oxalate deposits in bone marrow, skin, or other tissue (histologically confirmed);
    • nephrocalcinosis;
    • calcium oxalate nephrolithiasis.

Exclusion Criteria:

  • Unwilling or unable to provide consent/assent.
  • Patients unable or unwilling to provide medical record information.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Andrea Kattah, M.D.

Closed-enrolling by invitation

What is this? (?)
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Andrea Kattah M.D.

(507) 284-2944


More information


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