A Phase 3 interventional study of Pegcetacoplan in C3 Glomerulopathy (C3G), Primary Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) and Recurrent Glomerular Disease After Kidney Transplantation, sponsored by Swedish Orphan Biovitrum. Recruiting at 33 sites in 10 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Swedish Orphan Biovitrum · Phase 3, Interventional, and Prevention
To assess the efficacy and safety of pegcetacoplan for the prevention of recurrent C3G or primary IC-MPGN in kidney transplant recipients
The PRESERVE study is a Phase 3b, multicenter, single-arm, open-label clinical trial designed to explore the efficacy and safety of pegcetacoplan in preventing or delaying the recurrence of C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN) following kidney transplantation. Recurrence of these diseases after transplantation is common and can lead to graft dysfunction and loss. Pegcetacoplan is a complement C3/C3b inhibitor that has demonstrated activity in patients with native kidney disease and recurrent disease after transplantation. The study aims to assess whether initiating pegcetacoplan at the time of kidney transplantation, before recurrence occurs, may delay the recurrence and support long-term graft outcomes. Participants will receive pegcetacoplan in addition to standard post-transplant care and will be followed to evaluate disease recurrence, kidney function, graft outcomes, safety, and tolerability.
33 studies on the registry are indexed under Glomerulonephritis, Membranoproliferative; 10 are open to participants now.
This study's planned enrollment of 30 is above the median of 22 across 26 interventional studies indexed under Glomerulonephritis, Membranoproliferative.
Browse Glomerulonephritis, Membranoproliferative studies →Swedish Orphan Biovitrum is the lead sponsor of 82 studies on the registry; 6 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 15 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Nov 4, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pegcetacoplan, a complement C3/C3b inhibitor, administered according to the study protocol in kidney transplant recipients with high risk of recurring C3G or primary IC-MPGN
Drug: Pegcetacoplan
Dose amount based on age and weight Subcutaneous infusion twice-a-week. Adult participants aged 18 years or older at enrolment: 1080 mg Adolescent participants aged 12 to 17 years at enrolment: * Weight ≥50 kg: 1080 mg * Weight 35 to \<50 kg: 648 mg 1st dose, then 810 mg subsequently * Weight 30 to \<35 kg: 540 mg for the first 2 doses, then 648 mg subsequently
Also known as: Aspaveli, Empaveli, APL-2
Occurrence of Clinically Significant Recurrent Disease
Histological evidence of recurrent disease based on the histopathological assessment of the kidney biopsy
Time frame: Within 2 years after kidney transplantation
Time to Onset of Clinically Significant Disease Recurrence
To explore the impact of pegcetacoplan on time to clinically significant recurrence of C3G or primary IC-MPGN after kidney transplantation
Time frame: Up to 2 years after kidney transplantation
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents. All requests are evaluated by a cross functional panel of experts within Sobi. Patient level data will be anonymized and study documents, if applicable, will be redacted to protect the privacy of trial participants.
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Jan 2031, 47 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Pegcetacoplan
Glomerulonephritis, Membranoproliferative →