A Study of Mitapivat in Participants With Sickle Cell Disease and Nephropathy (NCT06286046) | Clinical Trial Compass
WithdrawnPhase 2
A Study of Mitapivat in Participants With Sickle Cell Disease and Nephropathy
Stopped: Withdrawn prior to study start per sponsor decision. No patients were enrolled.
0Started 2026-03
Plain-language summary
The primary purpose of this study is to evaluate the effect of mitapivat on albumin creatinine ratio (ACR) response in participants with sickle cell disease (SCD) and nephropathy.
Who can participate
Age range16 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria:
* Age of 16 years or older (except in France where participants must be aged 18 years or older);
* Females must be post-menarche;
* Documented diagnosis of sickle cell disease (Homozygosity for hemoglobin S \[HbSS\] or Hemoglobin S/Beta 0 \[HbS/β0\]-thalassemia);
* Hemoglobin concentration ≥ 5.5 and ≤ 10.5 grams per deciliter (g/dL) during the Screening Period. If more than one measurement is collected during the Screening Period, the average must be ≥ 5.5 and ≤ 10.5 g/dL;
* If taking hydroxyurea, the dose of hydroxyurea must have been stable for at least 90 days before Study Day 1 with no planned dose adjustment during the study and no sign of hematologic toxicity;
* Discontinuation of hydroxyurea requires a 90-day washout before providing informed consent/assent;
* Two urine ACR results collected during the Screening Period, both of which must be ≥ 100 and \< 2000 milligrams per gram (mg/g). One ACR result can be from an untimed urine sample collected as part of a clinic visit. The other ACR result must be from a urine sample that is the first (or second) morning void on another day;
* One ACR result \> 100 mg/g within 24 weeks before providing informed consent/assent;
* If taking Angiotensin-converting enzyme (ACE) inhibitor or Angiotensin receptor blockers (ARB) therapy, must have been on stable dose for at least 90 days before providing informed consent/assent with no planned dose adjustment during the study;
* Women of childbearing potenti…
What they're measuring
1
Percentage of Participants With Albumin Creatinine Ratio (ACR) Response